At a glance
What is it—and why does it matter?
Leuprolide acetate is a chemically synthesized nine–amino-acid (nonapeptide) analog of endogenous gonadotropin-releasing hormone (GnRH/LH-RH). This case report notes improvement in pain symptoms after a three-month course of monthly leuprolide acetate injections. Do not use leuprolide acetate injection in patients with known hypersensitivity to GnRH, GnRH agonist analogs, or the injection’s excipients.
Each sentence above is copied from a published claim presentation. The links open its evidence record.
The initial hormone flare, depot interval, and indication must be interpreted from the exact product label. [1]Regulatory labelLupron Depot prescribing informationCurrent DailyMed prostate-cancer depot label with product-specific intervals and warnings.
Identity + structure
A molecule, not a product name.
| Preferred name | Leuprolide | Ingredient |
|---|---|---|
| Pharmacologic class | Gonadotropin-releasing hormone agonist | Profile record |
| Peptide structure | 9 amino acids | Profile record |
| Also indexed as | leuprolide · leuprolide acetate · leuprorelin | Search aliases |
Mechanism + clinical pharmacology
Target, response, and disposition.
Continuous GnRH receptor stimulation initially raises and then suppresses LH and FSH, reducing gonadal steroid production. [1]Regulatory labelLupron Depot prescribing informationCurrent DailyMed prostate-cancer depot label with product-specific intervals and warnings.
Evidence ledger
What the evidence says.
These are evidence statements, not individualized medical instructions. Product, dose, population, and study context remain attached to each source.
Study findings
What studies observed in defined populations, comparators, and time periods.
The clinical evidence summarized includes two multicenter, open-label, non-comparative studies enrolling 131 prostate cancer patients with follow-up/evaluation up to two years.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The label states leuprolide acetate lacks activity via oral administration, consistent with a peptide requiring non-oral delivery.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The absence of baseline chest imaging in this case limits attribution, because pre-existing subclinical pulmonary alveolar proteinosis could not be excluded.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The results report between-group differences favoring combined postoperative therapy (GnRH-a + LNG-IUS) over GnRH-a alone on overall response and symptom-related scales (VAS and Kupperman), with p < 0.05.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Continuous exposure to the GnRH agonist leuprolide acetate produces functional antagonism at the pituitary, inhibiting gonadotropin (LH/FSH) secretion.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
With initiation of single daily subcutaneous dosing in humans, leuprolide causes an initial pituitary gonadotropin rise (LH/FSH) with a transient rise in downstream gonadal steroids.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A controlled comparative study reported no difference in survival at two years between daily subcutaneous leuprolide acetate injection (1 mg/day) and diethylstilbestrol (3 mg/day).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Efficacy result: the proportion meeting the primary endpoint was 93.4%, with a 95% confidence interval of (89.2%, 97.6%).
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Among leuprolide-treated patients with confirmed FAH, 53.4% surpassed their mid-parental height (MPH) at FAH.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In juvenile male rats, extended-release leuprolide acetate depot exposure was not associated with a statistically significant change in body mass compared with control.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In a single-protein binding assay, CHEMBL1201199 showed high-affinity competitive inhibition of [125 I ]leuprorelin binding to a cloned human GnRH/LHRH receptor, with IC50 = 0.3 nM.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In a non-controlled, multiple-dose prostate cancer trial of the 22.5 mg depot, the proportion achieving and maintaining castrate testosterone (<50 ng/dL) from Day 28 through Day 168 was 94.3% (95% CI:89.4, 97.0).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Initial GnRH agonism with leuprolide acetate can produce an early, transient testosterone surge (tumor flare window differs by ELIGARD strength).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In early and fast puberty girls treated with Boennuokang® leuprorelin acetate microspheres, uterine length measured by pelvic ultrasonography decreased over 18 months, with statistical significance reported (P<0.001).
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
For the primary endpoint of sustained testosterone suppression to castrate levels through 48 weeks, the leuprolide group maintained castration in 88.8% of men, with a 95% confidence interval of 84.6 to 91.8.
1 cited source · 1 linked study ID
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The abstract reports endocrine marker differences at 6 months, with combined therapy associated with lower FSH, estradiol, and progesterone and higher LH versus the control regimen, all with p < 0.05.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
As a GnRH agonist, leuprolide (CAMCEVI) can produce an initial testosterone surge during week 1, followed by decline to baseline or below by the end of week 2.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
This within-cohort analysis reported reduced estradiol after 18 months of treatment, consistent with decreased gonadal steroid production under HPG-axis suppression.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
At study conclusion, maintenance of castration was reported for all patients, and most patients had testosterone at or below 0.2 ng/ml (92.8%).
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
This case report notes improvement in pain symptoms after a three-month course of monthly leuprolide acetate injections.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Oral administration is described as inactive, consistent with poor oral activity of this peptide in the source.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A controlled comparison reported similar two-year survival between subcutaneous leuprolide acetate 1 mg/day and diethylstilbestrol (DES) 3 mg/day.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
This early testosterone rise is described as transient and is associated with tumor flare risk; exact magnitude of increase is not provided here.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
With continuous daily dosing in humans, leuprolide acetate suppresses pituitary gonadotropins (LH/FSH) and thereby lowers gonadal steroids; these reductions occur within two to four weeks after starting treatment.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Leuprolide acetate treatment resulted in menstrual suppression in all treated patients.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In a juvenile rat model, sustained GnRH receptor agonism using extended-release leuprolide acetate depot was associated with reduced gonad size in both sexes.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In this single-patient report, post-treatment follow-up noted a decrease in endometriosis lesion size after leuprolide acetate injections.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In the FP01C-13-001 study, most patients achieved medical castration (testosterone ≤ 50 ng/dL) by Week 4 after the first injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In a rat pituitary membrane binding assay, leuprolide had IC50 = 0.5 nM for inhibiting radioligand binding.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In this retrospective comparison of leuprolide depot schedules with concomitant aromatase inhibitor, the primary endpoint (ovarian ablation) was achieved by all monthly-dosed patients and by 99% of those dosed every 3 months at 3 months, with no statistically significant difference (P = 1).
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In a rat pituitary membrane preparation, CHEMBL1201199 inhibited [125 I]leuprorelin receptor binding with IC50 = 0.5 nM, consistent with potent GnRH/LHRH receptor binding inhibition.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprolide acetate’s continuous administration suppresses male gonadal steroid production such that testosterone reaches castrate concentrations.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After the initial gonadotropin rise, continuous human administration of leuprolide acetate decreases pituitary gonadotropins (LH and FSH).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
During follow-up, nine instances of loss of testosterone suppression were observed; these events were not accompanied by PSA rise.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Duration finding: each depot injection maintained testosterone suppression across its full 24-week duration.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Oral administration is stated to be ineffective, consistent with peptide degradation in the gastrointestinal tract.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Post-dose result: after the second injection, mean testosterone did not show an increase.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Case 1 reported accelerated meningioma growth following initiation of leuprorelin acetate, leading to surgical resection.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The authors say these results are hypothesis-generating and need confirmation in future randomized controlled trials.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Time course result: by week 4, mean serum testosterone reached 15.9 ng dl(-1), described as below castrate levels.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Serologic evaluation in the case showed anti–granulocyte-macrophage colony-stimulating factor (GM-CSF) antibodies within the negative range (3.2 µg/mL; reference ≤ 5 µg/mL), arguing against autoimmune PAP in that patient.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In the one-implant cohort, nearly all patients achieved testosterone suppression below the stated castrate threshold (50 ng/dL) by week four.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After initiation of continuous leuprolide acetate, males experience suppression of testicular steroidogenesis such that serum testosterone reaches castrate levels within 2 to 4 weeks.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After ongoing daily administration, pituitary gonadotropins (LH and FSH) decrease.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
For uterine leiomyomata-associated anemia, depot leuprolide 3.75 mg is indicated as concomitant therapy with iron to improve hematologic status before surgery when 3 months of hormonal suppression is required.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
When comparing leuprolide depot administration schedules with an aromatase inhibitor, 1-year disease-free survival was similar between monthly and every-3-month dosing, with no statistically significant difference (P = .75).
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Systemic hormone concentrations of FSH and ACTH in serum were reduced in leuprolide acetate depot–treated animals.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprolide acetate treatment significantly reduced estradiol concentrations to menopausal levels in the treated group.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
This single-arm retrospective cohort reported declining FSH over 18 months during treatment, aligning with reduced pituitary gonadotropin output during GnRHa use.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
With continuous daily administration in humans, leuprolide acetate is stated to reduce gonadotropins (LH and FSH), consistent with pituitary downregulation after initial stimulation.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Comparing leuprolide depot schedules used with an aromatase inhibitor, 1-year overall survival was similar between monthly and every-3-month dosing (P = 1).
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Oral administration does not produce pharmacologic activity for leuprolide acetate, implying a non-oral route is required for effect.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 2 source records.
Formulation-A showed an initial post-dose rise in mean testosterone and LH followed by suppression by Week 4 to 16.0 ng/dL (testosterone) and 0.6 mIU/mL (LH).
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The questionnaire measured satisfaction, and 72% of participants indicated they were satisfied with height-related outcomes.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
This case report describes pulmonary alveolar proteinosis (PAP) being diagnosed during leuprorelin acetate therapy for ovarian endometrioma, emphasizing a temporal association rather than proven causation.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In juvenile female rats, administration of extended-release leuprolide acetate depot (a GnRH receptor agonist) was associated with higher body mass.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Sustained leuprolide acetate dosing suppresses testicular androgen production such that male testosterone falls below castrate threshold.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
As a monitored secondary endpoint in the Viadur clinical studies, PSA showed large reductions; the text reports the proportion of evaluable patients achieving at least 90% reduction at six months.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The approved use stated is palliative treatment in advanced prostatic cancer.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In the reported case, chest CT imaging detected bilateral ground-glass opacities (GGOs) one month after therapy initiation, and these imaging findings persisted on subsequent CT in November 2025.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
After initial pituitary stimulation, sustained daily dosing in humans decreases gonadotropins (LH/FSH), producing profound suppression of gonadal steroids—testosterone to castrate levels in males and estrogens to post-menopausal levels in pre-menopausal females—within two to four weeks.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
PSA outcome over time: mean PSA levels remained < 3 ng ml(-1) from week 14 through week 48 of treatment.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Early testosterone suppression by day 4 was not observed in the leuprolide group, with 0% reaching castrate testosterone levels at that time point.
1 cited source · 1 linked study ID
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In juvenile rats, extended-release leuprolide acetate depot was associated with reduced circulating (serum) concentrations of FSH and ACTH.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In this case, radiographic ground-glass opacities demonstrated regression on follow-up CT performed three months after completion of leuprorelin acetate therapy.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In endometriosis patients, leuprolide acetate produced statistically significant improvements in dysmenorrhea, pelvic pain, and pelvic tenderness versus placebo.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
For endometriosis, monthly depot leuprolide 3.75 mg has an indication that includes symptomatic pain relief and reduction of endometriotic lesions.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
On the questionnaire, 74% of participants reported satisfaction with psychological outcomes.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Continuous leuprolide exposure suppresses gonadal steroid production, with testosterone in males and estrogens in pre-menopausal females falling to castrate/post-menopausal ranges within two to four weeks.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After initiating therapy with a single implant, there is an initial testosterone surge (Day 3) followed by suppression below baseline by week two, as reflected in mean serum testosterone values.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Leuprolide acetate inhibits gonadotropin secretion.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After the initial stimulation phase, continuous daily exposure in humans is described as suppressing pituitary gonadotropins (LH/FSH) and reducing downstream sex steroids to castrate/post-menopausal ranges within two to four weeks.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Continuous daily leuprolide acetate administration downregulates pituitary gonadotropins, decreasing LH and FSH in humans.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In an in vivo rat endocrine assay (ovariectomized, estrogen/progesterone-treated), subcutaneous 100 ng CHEMBL1201199 increased luteinizing hormone release; the reported effect size was Ratio = 15.0 relative to LH-RH.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In juvenile male rats, extended-release leuprolide acetate depot did not produce a statistically significant change in the timing/occurrence of the pubertal landmark preputial separation compared with control.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Comparative evidence
How the studied intervention compared with another intervention, comparator, or threshold.
Using cumulative probability rankings for live birth rate, leuprorelin was ranked best at 99.9% compared with triptorelin and cetrorelix.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Between the two LA depot formulations, Formulation-A exhibited a reduced initial Cmax-like peak and higher concentrations during the sustained-release portion relative to Formulation-B.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
A randomized, double-blind, multicenter clinical study (n=52) evaluated leuprolide acetate depot suspension (Lupron depot) 3.75 mg compared with placebo for pain associated with endometriosis.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In this network meta-analysis, treatment ranking (cumulative probability) for clinical pregnancy rate placed leuprorelin highest at 97.8% versus cetrorelix, triptorelin, buserelin, and ganirelix.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Controlled trials reported that 6 months of monthly leuprolide depot (3.75 mg) produced symptom relief comparable to danazol 800 mg/day and reduced endometrial implant size on laparoscopy.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
When interventions were ranked by cumulative probability for reducing OHSS, leuprorelin’s value (21.2%) was not among the highest compared with cetrorelix (96.9%), buserelin (58.7%), and ganirelix (57.5%).
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In an open-label randomized study of men with prostate cancer and atherosclerotic cardiovascular disease, adjudicated major adverse cardiovascular events over 12 months were numerically 4.1% with leuprolide versus 5.5% with degarelix; the estimated hazard ratio (1.28) had a wide 95% CI (0.59–2.79) and P =0.53.
1 cited source · 1 linked study ID
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Mechanism
Source-backed statements about targets, pathways, and biological response.
Sustained leuprorelin exposure leads to pituitary desensitisation and/or receptor down-regulation, which suppresses circulating gonadotrophins and sex hormones.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprolide is presented as an example of an injectable luteinizing hormone–releasing hormone (LHRH) agonist used as a standard approach to induce androgen deprivation in prostate cancer, with noted early testosterone surge and delayed onset of therapeutic effect.
1 cited source · 1 linked study ID
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
As a GnRH agonist administered continuously, leuprolide acetate inhibits pituitary gonadotropin (LH/FSH) secretion.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
An initial GnRH agonist stimulation phase is described: daily subcutaneous dosing increases LH/FSH and transiently increases gonadal steroid concentrations (including testosterone/DHT in males).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Monthly LUPRON DEPOT 3.75 mg first briefly stimulates, then suppresses pituitary hormones; with monthly dosing it lowers gonadal steroid secretion, and this reverses after stopping.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Depot injections were developed by trapping leuprorelin in biodegradable polymer microspheres to avoid daily injections.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
As a GnRH agonist, continuous leuprolide acetate exposure produces receptor downregulation after an initial stimulation phase, reducing pituitary LH/FSH release.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In advanced prostate cancer, androgen deprivation therapy is used with the goal of reducing serum testosterone to castrate levels.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In this study, leuprorelin acetate is explicitly identified as a GnRH agonist, meaning it is categorized as acting on the gonadotropin-releasing hormone (GnRH) pathway.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprolide acetate activates the gonadotropin-releasing hormone receptor (GnRHR) with high potency.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Continuous exposure to the GnRH agonist leuprolide acetate leads to functional downregulation of the pituitary-gonadal axis, reducing gonadotropin secretion and downstream gonadal steroidogenesis.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Leuprolide is a synthetic agonist of the gonadotropin-releasing hormone (GnRH) receptor.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 1 source record. 1 publication group(s) lack a resolved study identity.
A GnRH agonist can cause an initial stimulatory phase; with chronic continuous dosing, leuprolide acetate downregulates the pituitary–gonadal axis leading to suppressed steroidogenesis, which reverses after drug discontinuation.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
As a long-acting GnRH analog, leuprolide depot produces a transient pituitary stimulation (flare) followed by sustained pituitary gonadotropin suppression with repeated monthly dosing, reducing gonadal steroid secretion; function is reversible after discontinuation.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
As a GnRH agonist, continuous exposure produces functional inhibition of gonadotropin secretion (per label mechanism statement).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Continuous leuprolide acetate exposure decreases circulating pituitary gonadotropins (LH and FSH) in humans.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Clinically, GnRH receptor agonism is used to suppress the hypothalamic-pituitary-gonadal (HPG) axis as a way to delay pubertal progression.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
After the initial gonadotropin surge, sustained GnRH agonism with leuprolide decreases LH/FSH and reduces serum testosterone to the castrate range (≤50 ng/dL) over about two to four weeks.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
As a long-acting GnRH analog, monthly depot leuprolide produces an initial pituitary stimulation followed by prolonged downregulation/suppression of pituitary gonadotropins.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Pharmacokinetics
How the studied compound is absorbed, distributed, metabolized, and cleared.
These PK values apply to 1 mg IV bolus dosing in healthy male volunteers and are model-dependent (two compartment model).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In healthy male volunteers given an intravenous bolus, leuprolide’s distribution is summarized by a mean steady-state Vd of 27 L.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
3 cited passages across 2 source records.
After intraperitoneal administration (1 mg/kg) in overnight fasted C57BL/6N mice, CHEMBL1201199 time to maximum concentration (Tmax) was 1.0 hr.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Human intravenous protein-binding assessment reported fraction unbound (Fu) = 0.54 for CHEMBL1201199.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Human intravenous pharmacokinetic clearance (CL) for CHEMBL1201199 was reported as 2.0 mL·min-1·kg-1.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Using a two-compartment model in healthy male volunteers given a 1 mg IV bolus, leuprolide showed mean systemic clearance of 7.6 L/h and terminal elimination half-life of ~3 hours.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In healthy male volunteers given intravenous bolus leuprolide, distribution was characterized by a mean steady-state Vd of 27 L.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The PK parameters reported for an IV bolus (1 mg) in healthy male volunteers include mean systemic clearance (7.6 L/h) and a terminal elimination half-life of ~3 hours using a two-compartment model.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 2 source records.
Delayed absorption was parameterized with 3 transit compartments and a mean transit time of 34.1 days.
1 cited source · 1 linked study ID
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In rats given 100 ug/kg IV, leuprolide had CL = 9.0 mL/min/kg.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In children, leuprolide PK fit a one-compartment model with immediate and delayed first-order absorption (with proportional error).
1 cited source · 1 linked study ID
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In a rat intravenous pharmacokinetic measurement at 100 ug/kg, CHEMBL1201199 clearance (CL) was reported as 9.0 mL·min-1·kg-1.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
For the 7.5 mg depot, peak systemic exposure (Cmax) occurs within hours after subcutaneous injection, followed by sustained concentrations.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The PK profile reported for pediatric CPP shows an early peak concentration at 4 hours after subcutaneous 45 mg dosing, with mean Cmax 212.3 ng/mL.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Following intraperitoneal dosing (1 mg/kg) in overnight fasted C57BL/6N mice, CHEMBL1201199 reached Cmax = 157.1 nM.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In healthy male volunteers receiving an intravenous bolus, leuprolide distributed with a mean steady-state volume of distribution of 27 L.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
These PK data are from healthy female volunteers after a single dose; assay limitations are described elsewhere in the same section.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After a 1 mg intravenous bolus in healthy male volunteers, leuprolide pharmacokinetics reported include mean systemic clearance of 7.6 L/h and a terminal elimination half-life of approximately 3 hours based on a two compartment model.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In a small sample of 5 prostate cancer patients, the principal measured metabolite (M‑I) achieved peak plasma levels 2 to 6 hours after dosing and its peak was approximately 6% of the parent drug’s peak concentration.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The delayed absorption process for leuprolide was represented using a transit compartment model.
1 cited source · 1 linked study ID
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After intravenous bolus dosing in healthy male volunteers, the reported mean steady-state volume of distribution (Vdss) for leuprolide is 27 L.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 2 source records.
After a 1 mg IV bolus in healthy male volunteers, leuprolide shows mean systemic clearance 7.6 L/h and terminal half-life ~3 hours (two-compartment model).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In healthy male volunteers given an IV bolus, the reported mean steady-state Vd is 27 L.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In patients receiving the 1-month ELIGARD 7.5 mg depot, leuprolide shows an early Cmax followed by a decline over the 4-week interval.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After intravenous bolus dosing in healthy male volunteers, distribution was characterized by a mean steady-state volume of distribution of 27 L.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In vitro measurements indicate moderate plasma protein binding for leuprolide (43% to 49%) in human plasma.
1 cited source · 1 regulatory record
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Testosterone recovery assessment in a subgroup showed that 90 days after treatment discontinuation, mean testosterone remained 58.6 ng per deciliter in the leuprolide group.
1 cited source · 1 linked study ID
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Following subcutaneous implantation of Viadur, early systemic exposure shows a peak at 4 hours with lower concentrations by 24 hours, as given by mean serum concentrations.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A population pharmacokinetic (PK) model was developed to describe leuprolide exposure from a 3-month leuprolide acetate depot formulation in pediatric central precocious puberty.
1 cited source · 1 linked study ID
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Delayed absorption of leuprolide in children was modeled using transit compartments.
1 cited source · 1 linked study ID
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Systemic exposure data report mean Cmax values for leuprolide after the first and second CAMCEVI doses.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Vdss (steady-state volume of distribution) summarizes distribution relative to plasma after intravenous dosing; here, CHEMBL1201199 is reported with Vdss 0.38 L.kg-1 in humans.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 1 source record. 1 publication group(s) lack a resolved study identity.
After intramuscular LA 45 mg 6-month depot, leuprolide showed a peak-and-decline pattern early (first week) followed by a sustained phase with relatively constant mean concentrations through 24 weeks.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In healthy male volunteers, IV bolus leuprolide has a mean steady-state volume of distribution of 27 L.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In patients receiving the 3-month ELIGARD 22.5 mg depot, leuprolide has an early Cmax and declines across the 12-week interval.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The implant is reported to maintain steady systemic leuprolide exposure over a 12-month period, with a stated mean, range, and standard deviation.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
These PK parameters are given for 1 mg short-acting administration routes; depot formulations have different kinetics.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
For the 45 mg 6-month depot in prostate cancer patients, mean plasma concentrations show an early peak at 2 hours followed by decline over 24 weeks.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After intravenous bolus dosing in healthy male volunteers, leuprolide’s mean steady-state volume of distribution is reported as 27 L.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
This pharmacokinetic description is based on a study in 26 prostate cancer patients; it reports mean concentrations at specific time points.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The mean steady-state volume of distribution (Vd) reported for leuprolide after intravenous bolus dosing in healthy male volunteers is 27 L.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After a 1 mg intravenous bolus in healthy male volunteers, leuprolide showed mean systemic clearance of 7.6 L/h and a terminal elimination half-life of approximately 3 hours (two-compartment model).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After intravenous bolus dosing in healthy male volunteers, leuprolide’s reported mean steady-state volume of distribution is 27 L.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In overnight fasted C57BL/6N mice given 1 mg/kg IP, leuprolide reached Cmax = 157.1 nM.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Following initial dosing of the 22.5 mg depot, systemic exposure shows an early peak with mean plasma leuprolide concentration 46.8 ng/mL at approximately 2 hours.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The distribution parameter reported for leuprolide after intravenous bolus dosing in healthy male volunteers is a mean steady-state volume of distribution of 27 L.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After a 1 mg intravenous bolus in healthy male volunteers, leuprolide showed mean systemic clearance of 7.6 L/h and a terminal half-life of ~3 hours (two-compartment model).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The absorption profile for the 1-month 7.5 mg formulation shows an early Cmax followed by decline over the dosing interval.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In healthy male volunteers receiving an intravenous bolus dose, leuprolide’s mean steady-state volume of distribution (Vdss) was 27 L.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The sampling plan included PK measurement of leuprolide in an approximately 24-subject subset per cohort, with pharmacodynamic hormones (testosterone and LH) measured across all subjects.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
After IV bolus dosing in healthy male volunteers, leuprolide distributes with a mean steady-state Vd of 27 L.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 2 source records.
Protein binding measured in vitro indicates leuprolide has moderate binding to human plasma proteins (43%–49%).
3 cited sources · 3 regulatory records
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
3 cited passages across 3 source records.
In patients receiving the 4-month ELIGARD 30 mg depot, leuprolide peaks within hours and declines over the 16-week interval.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
For a 1 mg IV bolus in healthy male volunteers, the source reports systemic clearance (7.6 L/h) and terminal elimination half-life (~3 hours) using a two-compartment model.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
For the 22.5 mg depot given every three months, the label reports early post-injection peaks at about 5 hours after both the first and second injections.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In healthy female volunteers, leuprolide depot 3.75 mg given intramuscularly produced an early Cmax at 4 hours in the range 4.6–10.2 ng/mL.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The selected structural-error PK model for pediatric leuprolide included one compartment, dual (immediate and delayed) first-order absorption, and proportional residual error.
1 cited source · 1 linked study ID
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Following a 1 mg IV bolus in healthy male volunteers, leuprolide showed a mean systemic clearance of 7.6 L/h and a terminal half-life of ~3 hours (two-compartment model).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Human intravenous pharmacokinetic measurement reported a terminal half-life (T1/2) of 2.9 hr for CHEMBL1201199.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In an in vitro proteolysis stability assay, the chymotrypsin degradation half-life (T1/2) for CHEMBL1201199 was 0.01667 hr.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In the population PK model, leuprolide parameter estimates included apparent clearance (181 L/day) and apparent volume (7.11 L).
1 cited source · 1 linked study ID
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In patients receiving the 6-month ELIGARD 45 mg depot, leuprolide reaches a Cmax within hours and declines across the 24-week interval.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Safety findings
Observed or labeled risks, adverse effects, and safety signals.
Post-exposure reports associate GnRH agonist therapy (including LUPRON DEPOT) with SCARs such as SJS/TEN, DRESS, and AGEP.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A known early pharmacodynamic effect of GnRH agonists is an initial testosterone surge (“tumor flare” risk period), with timing noted by formulation strength in the label.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The warning describes metabolic adverse effects associated with GnRH agonism, including dysglycemia and lipid abnormalities.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Long-term rodent carcinogenicity testing reported pituitary proliferative lesions in rats at higher daily subcutaneous doses of leuprolide acetate.
1 cited source · 1 regulatory record
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
An early ‘tumor flare’ risk is linked to a temporary testosterone rise after starting leuprolide acetate depot formulations, with timing differing by strength.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 1 source record.
By inducing a hypoestrogenic state, leuprolide depot can reduce bone mineral density, with potential incomplete recovery after discontinuation.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The label states LUPRON should not be used in women who are or may become pregnant, citing potential fetal harm if administered during pregnancy.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
By inducing a hypoestrogenic state, leuprolide depot therapy can decrease bone mineral density, with potential for incomplete recovery post-treatment.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A serious safety risk listed is SCARs (e.g., SJS/TEN, DRESS, AGEP) occurring in patients receiving leuprolide acetate.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A known early pharmacodynamic effect (tumor flare phenomenon) is an initial testosterone rise of approximately 50% above baseline during the first weeks of therapy.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The source states clinical safety in pregnancy is not established and warns of potential fetal harm with leuprolide acetate exposure.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The label warns that leuprolide acetate depot 11.25 mg may cause fetal harm if given during pregnancy and therefore is contraindicated in pregnant women.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Based on animal reproduction studies and mechanism, leuprolide depot can cause embryo-fetal harm, so it is contraindicated in pregnancy.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A recognized early-on therapy effect of GnRH agonists including LUPRON DEPOT is an initial testosterone surge (about 50% above baseline) in the first weeks.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
LUPRON DEPOT 3.75 mg can lower estrogen levels and cause bone mineral density loss that may not fully reverse after stopping.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
An initial GnRH-agonist stimulatory phase can temporarily increase gonadotropins and sex steroids above baseline, potentially causing transient pubertal signs such as vaginal bleeding.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Contraindications
Circumstances in which a specific product label says it should not be used.
Contraindication: hypersensitivity to GnRH, GnRH agonist analogs, or CAMCEVI excipients precludes use of leuprolide (CAMCEVI).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The contraindication is known hypersensitivity to GnRH, GnRH agonist analogs, or any listed excipients in the leuprolide acetate injection formulation.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 2 source records.
The contraindications include hypersensitivity to GnRH-related agents (GnRH or GnRH agonists) or to formulation components.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
This contraindication is based on known hypersensitivity to the hormone class or formulation components.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A labeled contraindication is known hypersensitivity to GnRH agonists or any excipient contained in LUTRATE DEPOT.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The contraindication includes known hypersensitivity to GnRH, GnRH agonist analogs, or any excipients in the leuprolide acetate injection formulation.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 2 source records.
The label lists hypersensitivity to GnRH/GnRH agonist analogs or product components as a contraindication.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The contraindication is known hypersensitivity to GnRH, GnRH agonist analogs, or any formulation excipients (risk includes reported anaphylactic reactions in literature).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The label lists hypersensitivity to GnRH, GnRH agonist analogs, or any excipients as a contraindication.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 1 source record.
The labeled contraindication includes hypersensitivity reactions to the active class (GnRH/GnRH agonist analogs) or formulation components.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A labeled contraindication is prior known hypersensitivity to GnRH agonists or to any excipient contained in the depot suspension formulation.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A labeled contraindication is prior known hypersensitivity to GnRH agonists or to any excipient contained in this depot suspension.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
This contraindication is based on known hypersensitivity; the section also references reports of anaphylactic reactions in the literature.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The label lists a contraindication for known hypersensitivity to GnRH, GnRH agonist analogs, or formulation excipients.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A stated contraindication is known hypersensitivity to GnRH, GnRH agonist analogs, or any excipient components of the injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeling identifies pregnancy as a contraindication for leuprolide acetate (FENSOLVI) and states potential for fetal harm.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A listed contraindication is known hypersensitivity to GnRH, other GnRH agonist analogs, or CAMCEVI excipients.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The product lists a contraindication for individuals with hypersensitivity to GnRH or related agonist analogs, as well as to any formulation component.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The label lists hypersensitivity to GnRH, GnRH agonists, or any formulation component as a contraindication for leuprolide acetate (FENSOLVI).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A contraindication is known hypersensitivity to GnRH, GnRH agonist analogs, or any excipient in the injection product.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Known hypersensitivity to GnRH agonists or product excipients is a labeled contraindication.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A labeled contraindication is known hypersensitivity to GnRH, GnRH agonist analogs, or any excipients contained in leuprolide acetate injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The label lists pregnancy as a contraindication and states potential fetal harm.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Do not use if the person is hypersensitive to GnRH agonists or to any ingredient in the product.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Oral administration is stated to be inactive, consistent with a peptide drug that is not active by the oral route as labeled.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A contraindication is known hypersensitivity to GnRH, GnRH agonist analogs, or any excipients present in the leuprolide acetate injection product.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Contraindication includes known hypersensitivity to GnRH, GnRH agonist analogs, or any excipient in the formulation.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A labeled contraindication for leuprolide acetate (ELIGARD) is hypersensitivity to GnRH-related compounds or product excipients.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The product is contraindicated when there is known hypersensitivity to GnRH, GnRH agonist analogs, or formulation excipients.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Contraindication is stated for known hypersensitivity to GnRH-related agents (GnRH or GnRH agonist analogs) or to any excipient in the product.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The contraindication is based on hypersensitivity risk; the label also notes anaphylactic reactions have been reported in the literature.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A labeled contraindication for CAMCEVI is known hypersensitivity to GnRH, GnRH agonist analogs, or any excipients in the product.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The contraindication is based on hypersensitivity history; the section also notes anaphylactic reactions to GnRH agonists have been reported in the medical literature.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A labeled contraindication is known hypersensitivity to GnRH agonists or to any excipient contained in LUPRON DEPOT.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The contraindication includes known hypersensitivity to GnRH, GnRH agonist analogs, or any excipient in the leuprolide acetate injection formulation.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Do not use leuprolide acetate injection in patients with known hypersensitivity to GnRH, GnRH agonist analogs, or the injection’s excipients.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 2 source records.
Do not use leuprolide acetate injection in people who are hypersensitive to GnRH, GnRH agonist analogs, or its excipients.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Contraindication: leuprolide acetate depot 11.25 mg is contraindicated in women with hypersensitivity to GnRH, GnRH agonist analogs (including leuprolide acetate), or any excipients in the product.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The contraindication is hypersensitivity to the GnRH pathway peptides/analogs or formulation components.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Interactions
Source-backed product and drug interaction statements.
The labeling reports absence of dedicated drug–drug interaction studies for the 3.75 mg leuprolide depot formulation.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The label states that formal drug–drug interaction studies have not been performed with this 3.75 mg depot formulation.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
By suppressing the pituitary–gonadal axis, therapeutic dosing can interfere with diagnostic testing of pituitary gonadotropins and gonadal function during therapy and up to 3 months post-discontinuation.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The source explicitly states that pharmacokinetic-based drug–drug interaction studies have not been conducted for leuprolide acetate.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
No pharmacokinetic drug-drug interaction studies were done with ELIGARD.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
No pharmacokinetic drug–drug interaction studies have been done for leuprolide acetate.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
No pharmacokinetic drug–drug interaction studies have been conducted for leuprolide acetate.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
This statement is about route of administration (oral inactivity), not a drug-drug interaction.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Regulatory status
Product-, indication-, and jurisdiction-specific regulatory records.
The labeled indication states leuprolide acetate injection (LUPRON INJECTION) is used palliatively in advanced prostatic cancer.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled indication for leuprolide acetate (FENSOLVI) includes treating central precocious puberty (CPP) in pediatric patients starting at age 2 years.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The label includes an indication for leuprolide depot 11.25 mg given with iron therapy to improve hematologic status preoperatively in women with fibroid-related anemia when three months of hormonal suppression is considered necessary.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The approved use stated is palliative treatment in advanced prostatic cancer.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 2 source records.
LUPRON DEPOT (leuprolide acetate) is indicated to treat advanced prostate cancer.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled indication is palliative treatment of advanced prostatic cancer.
3 cited sources · 3 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
3 cited passages across 3 source records.
The labeled indication is palliative treatment for advanced prostatic cancer.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The approved indication stated is treatment of advanced prostate cancer in adult patients.
3 cited sources · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
3 cited passages across 3 source records.
The labeled indication is palliation in advanced prostatic cancer.
4 cited sources · 4 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
4 cited passages across 4 source records.
Leuprolide acetate depot suspension (22.5 mg, 3-month) is used to treat advanced prostate cancer.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled indication for leuprolide acetate depot suspension 22.5 mg (3-month administration) is advanced prostate cancer treatment.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled indication for ELIGARD (a leuprolide acetate product) is palliative treatment in advanced prostate cancer.
3 cited sources · 3 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
4 cited passages across 3 source records.
The labeled indication is palliative treatment for advanced prostatic cancer.
3 cited sources · 3 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
4 cited passages across 3 source records.
The labeled indication states leuprolide acetate (FENSOLVI) is used in pediatric central precocious puberty starting at age 2 years.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled indication includes palliative treatment of advanced prostatic cancer.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 1 source record.
The labeled indication is palliative treatment of advanced prostatic cancer.
6 cited sources · 6 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
6 cited passages across 6 source records.
The product’s approved indication is treatment of central precocious puberty in pediatric patients.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 1 source record.
The label states an approved indication for leuprolide acetate depot 11.25 mg to manage endometriosis, including symptomatic pain relief and reduction of endometriotic lesions.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled indication for leuprolide acetate depot (LUPRON DEPOT) is treatment of advanced prostate cancer.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled indication for leuprolide acetate 22.5 mg depot (3‑month formulation) is treatment of advanced prostate cancer.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The approved use stated is palliative treatment of advanced prostatic cancer with leuprolide acetate injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled indication for LUTRATE DEPOT 22.5 mg (leuprolide acetate depot) is treatment of advanced prostate cancer.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled indication for LUPRON DEPOT (leuprolide acetate) is treatment of advanced prostate cancer.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The indication states that leuprolide acetate (VABRINTY) is intended for treatment of advanced prostate cancer.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled indication is palliative treatment of advanced prostatic cancer.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
3 cited passages across 2 source records.
Administration
Product-specific route, timing, formulation, and use instructions—not universal dosing advice.
Leuprolide acetate injection is meant to be given under the skin (subcutaneous injection).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
This leuprolide acetate formulation is administered subcutaneously as a depot that provides continuous drug release across 1-, 3-, 4-, or 6-month dosing intervals.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Give LUPRON DEPOT-PED as a single intramuscular injection (gluteal area, anterior thigh, or shoulder) right after mixing; discard if not used within 2 hours.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The product is formulated as a sterile aqueous solution for subcutaneous administration.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The source states leuprolide acetate lacks activity with oral administration, consistent with limited oral bioactivity for this peptide.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The product is formulated as a sterile aqueous solution for subcutaneous administration; the vial volume and concentration are 2.8 mL and 5 mg/mL, respectively.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The dosing interval for leuprolide acetate depot 11.25 mg should not be shorter than every 3 months.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
ELIGARD is a subcutaneous depot formulation designed for continuous release over dosing intervals of one, three, four, or six months.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Administration is restricted to delivery by a healthcare provider.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
This depot product is supplied as lyophilized microspheres and is administered intramuscularly as a single injection on a 12-week schedule.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Administration of the 3.75 mg leuprolide depot formulation is restricted to healthcare-professional administration.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Administration requirement: leuprolide acetate depot 11.25 mg is required to be administered by a healthcare professional.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The product is formulated as a sterile aqueous solution designed for subcutaneous administration.
7 cited sources · 7 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
9 cited passages across 7 source records.
The reconstitution instructions specify the final concentration (45 mg/0.375 mL) and a limited in-use time window (30 minutes).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Oral administration does not produce activity for leuprolide acetate, consistent with peptide drugs being inactivated in the GI tract.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Permitted intramuscular injection sites include gluteal area, anterior thigh, or shoulder.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Oral administration does not produce activity for leuprolide acetate, consistent with peptide degradation/poor oral bioavailability.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
3 cited passages across 2 source records.
The depot microsphere powder is reconstituted to a suspension and administered as a single intramuscular injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The product is formulated as a sterile aqueous solution for subcutaneous administration.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 2 source records.
The product formulation is an aqueous sterile solution designed for subcutaneous administration.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Reconstitution yields a suspension concentration of leuprolide acetate (FENSOLVI) of 45 mg per 0.375 mL.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After reconstitution, the prepared suspension is intended for immediate administration.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 1 source record.
After reconstitution, the depot suspension is administered intramuscularly at a 90-degree angle, rotating among recommended IM sites (gluteal, anterior thigh, deltoid).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The dosage form of leuprolide in CAMCEVI is a sterile formulation intended for subcutaneous injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
For the 7.5 mg monthly depot, the lyophilized microspheres are reconstituted and administered intramuscularly as a single injection on a 4-week schedule.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled product form is an aqueous sterile solution intended for the subcutaneous route.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
This implies an oral route is ineffective; the label supports use by injection rather than oral dosing.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A healthcare professional must administer LUPRON DEPOT 3.75 mg.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeling specifies a 30-minute post-reconstitution administration window for leuprolide acetate (FENSOLVI), after which the product should be discarded.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The product is formulated as a sterile aqueous solution designed for subcutaneous administration.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 1 source record.
Label-recommended regimen is 1 mg (0.2 mL/20 units) given as a single daily subcutaneous injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Leuprolide acetate injection is a sterile, clear solution for subcutaneous injection; it comes in a 2.8 mL multi-dose vial (5 mg/mL).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
For the 45 mg 6-month depot, the lyophilized microspheres are reconstituted and administered intramuscularly as a single injection on a 24-week schedule.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
A healthcare provider must administer LUPRON DEPOT.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
After reconstitution into a suspension, LUTRATE DEPOT should be administered immediately to avoid delay-related issues (e.g., separation).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
This depot product consists of lyophilized microspheres that require reconstitution prior to administration as a single intramuscular injection on a 12-week schedule.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 1 source record.
Dose records
Product- and indication-specific dose statements preserved separately to prevent unsafe generalization.
The dosing frequency for LUPRON DEPOT 3.75 mg should not exceed monthly administration.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
For the fibroids indication, the label recommends a single intramuscular 11.25 mg leuprolide depot injection intended to provide a three-month treatment course.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In the fibroids indication, dosing is monthly intramuscular administration, with a maximum duration of three months.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The dosing regimen specifies 1 mg per day delivered subcutaneously (0.2 mL; 20 unit mark) as a single daily injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
This table provides recommended injection intervals for each depot strength; it does not describe dose adjustments or patient-specific tailoring.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
For dosing every 3 months, LUPRON DEPOT-PED is a single intramuscular injection of 11.25 mg or 30 mg every 12 weeks.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Recommended dosing for the 22.5 mg 3-month depot is a single injection administered every 12 weeks.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The Viadur implant is specified to provide a nominal continuous daily delivery rate of leuprolide acetate over a 12-month period.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Recommended dosing is 1 mg injected under the skin once daily.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled regimen specifies 1 mg leuprolide acetate delivered as 0.2 mL by daily subcutaneous injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
For monthly dosing, LUPRON DEPOT-PED is given as a single intramuscular injection once a month at 7.5 mg, 11.25 mg, or 15 mg, starting based on body weight.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Recommended dose: 1 mg once daily by subcutaneous injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Recommended dosing for the 30 mg 4-month depot is a single injection on a 16-week schedule.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Recommended administration is 1 mg (0.2 mL; 20 unit mark) as a single daily subcutaneous injection.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 2 source records.
For fibroids, LUPRON DEPOT 3.75 mg is given as 1 IM injection every month for up to 3 months.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled 3-month regimen is a single-dose intramuscular injection given every 12 weeks using strengths 11.25 mg or 30 mg.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The product’s recommended regimen is 1 mg per day given subcutaneously as one daily injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Recommended leuprolide (CAMCEVI) regimen is 42 mg subcutaneously at 6-month dosing intervals.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled recommended regimen is 1 mg per day, delivered subcutaneously as 0.2 mL (20 units) once daily.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled 1-month regimen is a single-dose intramuscular injection administered monthly using strengths 7.5 mg, 11.25 mg, or 15 mg.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled 6-month regimen is a single-dose intramuscular injection administered every 24 weeks at 45 mg.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
For dosing every 6 months, LUPRON DEPOT-PED is a single intramuscular injection of 45 mg every 24 weeks.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Recommended maintenance dosing for the 7.5 mg 1-month depot is a single injection on a 4-week schedule.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Label-recommended regimen is 1 mg leuprolide acetate (0.2 mL; 20 unit mark) by single daily subcutaneous injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Label-recommended regimen is 1 mg leuprolide acetate given once daily via subcutaneous injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
For LUTRATE DEPOT 22.5 mg (3-month depot), labeled dosing is a single injection repeated every 12 weeks.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The dosing instruction specifies a daily subcutaneous regimen delivering 1 mg in 0.2 mL (20 unit mark).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In the fibroids regimen, leuprolide depot 3.75 mg is dosed as a monthly intramuscular injection for a maximum of 3 months.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The labeled regimen specifies 1 mg per day administered subcutaneously as a single daily injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
This states the labeled recommended dose and frequency for this product; it does not specify treatment duration.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
For the 22.5 mg 3‑month depot, the labeled dosing interval is every 12 weeks (single injection per interval).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
The product labeling specifies a fixed-dose, long-acting subcutaneous regimen: 45 mg every six months, administered by a healthcare professional.
2 cited sources · 2 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 2 source records.
Recommended dosing for the 45 mg 6-month depot is a single injection administered every 24 weeks.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
For the 22.5 mg 3-month depot formulation, the recommended regimen is one injection every 12 weeks.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 1 source record.
The labeled regimen specifies daily subcutaneous administration of 1 mg, corresponding to 0.2 mL or the 20 unit mark on the syringe.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Recommended dosing is 1 mg subcutaneously once daily.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Recommended dosing is 42 mg leuprolide by subcutaneous administration with a 6-month dosing interval.
2 cited sources · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 2 source records.
Label-recommended regimen is 1 mg leuprolide acetate (0.2 mL; 20 unit mark) via daily subcutaneous injection.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Identity
Ingredient, molecule, and product identity statements.
Leuprolide acetate is a chemically synthesized nine–amino-acid (nonapeptide) analog of endogenous gonadotropin-releasing hormone (GnRH/LH-RH).
7 cited sources · 7 regulatory records
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
7 cited passages across 7 source records.
Leuprolide acetate is a man-made peptide modeled on the endogenous GnRH peptide, consisting of nine amino acids (a nonapeptide analog).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In this work, leuprolide acetate is treated as a model hydrophilic peptide for encapsulation in core–shell PLGA microspheres produced via a three-phase glass capillary microfluidic approach.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprolide acetate is an engineered (synthetic) nine–amino-acid peptide designed as an analog of endogenous gonadotropin-releasing hormone (GnRH/LH-RH).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Leuprolide acetate is a man-made (synthetic) nonapeptide analog of endogenous gonadotropin-releasing hormone (GnRH).
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
As a GnRH analog peptide, continuous exposure to leuprolide acetate inhibits pituitary gonadotropin secretion and reduces gonadal steroidogenesis.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Leuprolide acetate is classified as a GnRH agonist.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The label identifies leuprolide acetate as a synthetic nonapeptide analog of endogenous GnRH, classified pharmacologically as a GnRH agonist.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In this record, leuprolide is categorized under the molecule type “Protein.”
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprolide acetate (LA) is described as an agonist of gonadotropin-releasing hormone (GnRH) and is clinically available.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 1 source record. 1 publication group(s) lack a resolved study identity.
The product is formulated as a sterile aqueous solution for subcutaneous administration.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Leuprolide acetate is a manufactured nonapeptide designed as an analog of endogenous GnRH.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Leuprolide acetate is a lab-made 9–amino-acid (nonapeptide) analog of GnRH (LH-RH) that acts as a GnRH agonist.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Leuprolide acetate is a man-made peptide composed of nine amino acids (a nonapeptide).
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprorelin acetate acts as a gonadotropin-releasing hormone (GnRH) agonist.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Histopathology in Case 1 identified fibrous meningioma with immunopositivity for LHRH and LHRH receptor expression.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprolide is classified as a gonadotropin-releasing hormone (GnRH) agonist and is used clinically to suppress ovarian function in premenopausal breast cancer patients.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The labeled injection formulation is a sterile aqueous solution for subcutaneous administration, supplied as a 2.8 mL multiple-dose vial at a concentration of 5 mg/mL leuprolide acetate.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Leuprorelin acetate microspheres for injection is classified as a gonadotropin-releasing hormone agonist (GnRH-a).
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
2 cited passages across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprolide, with INN leuprorelin, is classified as a peptide (Ligand ID: 1175).
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The molecular formula listed for leuprolide is C59H84N16O12.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
CAMCEVI is formulated as sterile leuprolide mesylate intended for subcutaneous administration.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
Leuprolide acetate is a manufactured nine–amino-acid peptide designed as an analog of endogenous GnRH (LH-RH), with higher potency than native GnRH.
1 cited source · 1 regulatory record
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record.
In Case 2, both primary and recurrent meningioma specimens showed LHRH and LHRH receptor positivity.
1 cited source · Study independence not established
Animal or laboratory findings do not establish benefit or safety in people.
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Additional research & classification gaps
36 archived statements are kept separate from drug-effect findings. Media studies, economic models, methods, and records with unresolved scope are not used as medical-effect evidence.
Inspect contextual research (36)
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
A 1 mg non-depot subcutaneous injection reaches a mean peak of 32–35 microg/L at 36–60 minutes.
Research context only—not evidence of a treatment effect.
- Clinical pharmacokinetics of depot leuprorelin.
compared with 32 to 35 microg/L at 36 to 60 min after a subcutaneous injection of 1mg of a non-depot formulation.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The authors interpret the case as a temporal association between leuprorelin acetate and non-autoimmune pulmonary alveolar proteinosis, explicitly stating that causality cannot be inferred due to lack of baseline imaging.
Research context only—not evidence of a treatment effect.
- pubmed-42469731
This case shows a temporal relationship between leuprorelin acetate therapy and non-autoimmune PAP. However, causality cannot be inferred in the absence of baseline imaging. Only a temporal association can be observed.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The microfluidic process produced monodisperse (uniform) 80 μm core–shell microspheres, with shell thickness adjustable through flow-rate-ratio control.
Research context only—not evidence of a treatment effect.
- Microfluidic Engineering of Core-Shell PLGA Microspheres with Adjustable Shell Thickness for Long-Acting Delivery of Leuprolide Acetate.
It was shown that uniform microspheres of 80 μm with distinct core-shell structure were formed using this device, and shell thickness was successfully regulated via the control of the flow rate ratios.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The survey captured reasons for initiating leuprorelin acetate, and respondents most frequently cited improving final height as the motivation.
Research context only—not evidence of a treatment effect.
- pubmed-42415823
Although treatment was initiated at a mean age of 8.86 yr, when the height benefit was limited, improving final height was the most common reason for treatment initiation.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
3 cited passages across 1 source record. 1 publication group(s) lack a resolved study identity.
Forced-degradation testing reported 7.47% degradation of leuprolide acetate under basic conditions.
Research context only—not evidence of a treatment effect.
- pubmed-42299119
During the stress study, the drug showed substantial degradation in acidic (14.34%), basic (7.47%), and thermal (5.70%) conditions.
- pubmed-42299119
During the stress study, the drug showed substantial degradation in acidic (14.34%), basic (7.47%)
- pubmed-42299119
During the stress study, the drug showed substantial degradation in acidic (14.34%)
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
This survey reports the mean age at which leuprorelin acetate treatment was started in the respondent group as 8.86 yr.
Research context only—not evidence of a treatment effect.
- pubmed-42415823
Although treatment was initiated at a mean age of 8.86 yr, when the height benefit was limited, improving final height was the most common reason for treatment initiation.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Adjusting flow-rate ratios in the microfluidic process enabled successful regulation of microsphere shell thickness.
Research context only—not evidence of a treatment effect.
- Microfluidic Engineering of Core-Shell PLGA Microspheres with Adjustable Shell Thickness for Long-Acting Delivery of Leuprolide Acetate.
and shell thickness was successfully regulated via the control of the flow rate ratios.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The authors state the findings do not mean GnRH treatment improves final height.
Research context only—not evidence of a treatment effect.
- pubmed-42415823
These findings do not imply that GnRH treatment improves final height.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In treated early and fast puberty girls, FSH (median, Q1–Q3) declined from baseline (T0) to month 18 (T4), consistent with decreased pituitary gonadotropin output over time.
Research context only—not evidence of a treatment effect.
- pubmed-42591741
the median (Q1-Q3) FSH decreased from 5.27 (4.82-6.10) mIU/mL at T0 to 2.00 (1.56-2.42) mIU/mL at T4
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Maturation index: the combination regimen (leuprorelin acetate plus rhGH) was associated with a lower bone age/chronological age (BA/CA) ratio than leuprorelin acetate monotherapy, with significance reported (allP<0.05).
Research context only—not evidence of a treatment effect.
- Therapeutic efficacy of leuprorelin acetate combined with rhGH in girls with ICPP and Its impact on body height and secondary sexual characteristics.
Following treatment, body height and weight of girls in the study group were significantly greater than those in the control group, while the bone age/chronological age (BA/CA) ratio
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The three-phase glass capillary microfluidic device produced uniform PLGA microspheres approximately 80 μm in size with distinct core-shell morphology.
Research context only—not evidence of a treatment effect.
- Microfluidic Engineering of Core-Shell PLGA Microspheres with Adjustable Shell Thickness for Long-Acting Delivery of Leuprolide Acetate.
It was shown that uniform microspheres of 80 μm with distinct core-shell structure were formed using this device,
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Self-reported treatment burden was low in this survey: 63.9% of respondents indicated no burden despite monthly injections over an average of 3 yr.
Research context only—not evidence of a treatment effect.
- pubmed-42415823
Despite monthly injections over an average of 3 yr, 63.9% of the respondents reported no treatment burden.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The authors explicitly caution that the reported satisfaction and survey findings should not be interpreted as evidence that GnRH treatment improves final height.
Research context only—not evidence of a treatment effect.
- pubmed-42415823
These findings do not imply that GnRH treatment improves final height.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In treated early and fast puberty girls, LH (median, Q1–Q3) declined from baseline (T0) to month 18 (T4), indicating reduced gonadotropin secretion over follow-up.
Research context only—not evidence of a treatment effect.
- pubmed-42591741
the median [quartile 1 (Q1)-quartile 3 (Q3)] LH decreased from 2.7 (2.23-3.51) mIU/mL at T0 to 0.66 (0.48-1.22) mIU/mL at T4
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprorelin is reported to achieve testosterone concentrations associated with castration within 3 to 4 weeks.
Research context only—not evidence of a treatment effect.
- Leuprorelin. A review of its pharmacology and therapeutic use in prostatic disorders.
Testosterone levels associated with castration are attained within 3 to 4 weeks.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprolide acetate reduces pituitary gonadotrope release of the gonadotropins LH and FSH.
Research context only—not evidence of a treatment effect.
- Leuprolide acetate: a drug of diverse clinical applications.
leuprolide acetate suppresses gonadotrope secretion of luteinizing hormone and follicle-stimulating hormone
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Hormonal effects: compared with leuprorelin acetate monotherapy, the combination with rhGH was associated with lower post-treatment serum estradiol (E2), FSH, and LH, with statistical significance indicated (allP<0.05).
Research context only—not evidence of a treatment effect.
- Therapeutic efficacy of leuprorelin acetate combined with rhGH in girls with ICPP and Its impact on body height and secondary sexual characteristics.
serum levels of estradiol(E2), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were notably lower in the study group (allP<0.05).
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprolide acetate served as the model active ingredient to study PLGA-based in situ-forming implant behavior.
Research context only—not evidence of a treatment effect.
- pubmed-42529459
In this study, using leuprolide acetate as a model drug, we characterized the ISFIs using computed tomography (CT) imaging to explore the influence of PLGA end-cap on the implant's formation and drug-release behavior.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprorelin (leuprolide acetate) is a synthetic gonadotrophin-releasing hormone analogue, also referred to as an LHRH analogue.
Research context only—not evidence of a treatment effect.
- Leuprorelin. A review of its pharmacology and therapeutic use in prostatic disorders.
Leuprorelin (leuprolide acetate) is a synthetic analogue of gonadotrophin-releasing hormone (GnRH) [luteinising hormone-releasing hormone (LHRH)]
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprorelin (leuprolide acetate) is an analogue of gonadotrophin-releasing hormone (GnRH).
Research context only—not evidence of a treatment effect.
- Leuprorelin. A review of its pharmacology and therapeutic use in prostatic cancer, endometriosis and other sex hormone-related disorders.
Leuprorelin (leuprolide acetate) is a gonadotrophin-releasing hormone (GnRH) analogue
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
In ChEMBL, leuprolide is indexed under the molecule identifier CHEMBL1201199.
Research context only—not evidence of a treatment effect.
- LEUPROLIDE
ChEMBL ID: CHEMBL1201199
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The synonyms for leuprolide include the term “Leuprorelin slow release.”
Research context only—not evidence of a treatment effect.
- LEUPROLIDE
ABBOTT-43818 FREE BASE; CKD-841; Leuporelin; (-)-leuprolide; Leuprolide; Leuprorelin; Leuprorelina; Leuproreline; Leuprorelin slow release; NSC-377526; TAP-144 FREE BASE
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The provided synonyms list includes Leuprorelin as an alternative name for leuprolide.
Research context only—not evidence of a treatment effect.
- LEUPROLIDE
ABBOTT-43818 FREE BASE; CKD-841; Leuporelin; (-)-leuprolide; Leuprolide; Leuprorelin; Leuprorelina; Leuproreline; Leuprorelin slow release; NSC-377526; TAP-144 FREE BASE
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
This statement only indicates leuprolide acetate’s role as a model compound in a formulation/imaging study; it does not imply clinical efficacy.
Research context only—not evidence of a treatment effect.
- pubmed-42529459
In this study, using leuprolide acetate as a model drug, we characterized the ISFIs using computed tomography (CT) imaging to explore the influence of PLGA end-cap on the implant's formation and drug-release behavior.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
ChEMBL lists LEUPROLIDE as the preferred name for CHEMBL1201199.
Research context only—not evidence of a treatment effect.
- LEUPROLIDE
Preferred name: LEUPROLIDE
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprolide is also referred to as ABBOTT-43818 FREE BASE in the listed synonyms.
Research context only—not evidence of a treatment effect.
- LEUPROLIDE
ABBOTT-43818 FREE BASE; CKD-841; Leuporelin; (-)-leuprolide; Leuprolide; Leuprorelin; Leuprorelina; Leuproreline; Leuprorelin slow release; NSC-377526; TAP-144 FREE BASE
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
The marketed formulation contains leuprolide acetate (leuprolide in an acetate salt form).
Research context only—not evidence of a treatment effect.
- IUPHAR ligand commentary
The marketed formulation contains leuprolide acetate.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprolide acetate lowers gonadal sex steroid production downstream of reduced LH and FSH secretion.
Research context only—not evidence of a treatment effect.
- Leuprolide acetate: a drug of diverse clinical applications.
that subsequently suppresses gonadal sex steroid production
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
For the primary endpoint, the investigators operationalized ovarian ablation using hormone thresholds: estradiol < 40 pg/mL with follicle-stimulating hormone in the range 23 to 116 mU/mL at the 3-month assessment.
Research context only—not evidence of a treatment effect.
- Efficacy of Different Leuprolide Administration Schedules in Premenopausal Breast Cancer: A Retrospective Review.
defined as an estradiol concentration less than 40 pg/mL and a follicle-stimulating hormone concentration of 23 to 116 mU/mL after 3 months of treatment.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Computed tomography (CT) imaging was applied to characterize leuprolide acetate in situ-forming implants and assess how PLGA end-cap chemistry influences depot formation and release behavior.
Research context only—not evidence of a treatment effect.
- pubmed-42529459
In this study, using leuprolide acetate as a model drug, we characterized the ISFIs using computed tomography (CT) imaging to explore the influence of PLGA end-cap on the implant's formation and drug-release behavior.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprorelin primarily targets the anterior pituitary, producing an initial transient increase in gonadotrophin release.
Research context only—not evidence of a treatment effect.
- Leuprorelin. A review of its pharmacology and therapeutic use in prostatic cancer, endometriosis and other sex hormone-related disorders.
It acts primarily on the anterior pituitary, inducing a transient early rise in gonadotrophin release.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Leuprolide acetate induces pituitary desensitization, which reduces downstream gonadal steroidogenesis.
Research context only—not evidence of a treatment effect.
- pubmed-31869126
It acts through pituitary desensitization to suppress gonadal steroid production, resulting in reversible reductions in estrogen and testosterone levels.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
As a GnRH (LHRH) analogue, leuprorelin produces an initial LH stimulation with increased testicular androgen release, followed by profound hormonal suppression with continuous administration.
Research context only—not evidence of a treatment effect.
- Leuprorelin. A review of its pharmacology and therapeutic use in prostatic disorders.
which initially stimulates luteinising hormone (LH) and hence testicular androgen release; continuous administration then results in profound suppression of these hormones.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Microfluidic flow rate ratios were used as process parameters to tune the shell thickness of LA-loaded core-shell PLGA microspheres.
Research context only—not evidence of a treatment effect.
- Microfluidic Engineering of Core-Shell PLGA Microspheres with Adjustable Shell Thickness for Long-Acting Delivery of Leuprolide Acetate.
and the shell thickness of microspheres was tuned by controlling the flow rate ratios to explore its effect on LA loading and release.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Depot-leuprolide acetate (a GnRH-analog depot) can cause a short initial gonadotropin stimulation followed by suppression.
Research context only—not evidence of a treatment effect.
- Utility of a 40-minute LH level after depot leuprolide for diagnosis and treatment monitoring in girls with CPP.
Depot-leuprolide acetate (dLA), used for the treatment of CPP, stimulates gonadotropins briefly before suppressing them.
1 cited source · Study independence not established
How to read this evidence
Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.
1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.
Analytical sensitivity was reported with LOD ranging 0.092-0.274 μg/mL and LOQ ranging 0.244-0.829 μg/mL for leuprolide acetate and its known impurities.
Research context only—not evidence of a treatment effect.
- pubmed-42299119
The method showed a good limit of detection (0.092-0.274 μg/mL) and quantification limits (0.244-0.829 μg/mL) for LPA and its known impurities.
Safety + tolerability
Risks, organized for scanning.
Contraindications
- Pregnancy for products where fetal harm applies
- Serious hypersensitivity to GnRH analogs or excipients
- Product-specific restrictions
Common effects
- Hot flashes
- Injection-site reactions
- Sweating
- Fatigue
- Sexual dysfunction
- Headache
Serious risks
- Tumor flare and transient symptom worsening
- Metabolic and cardiovascular effects
- Bone mineral density loss
- QT prolongation
- Convulsions
- Psychiatric effects
Structured from current product labeling [1]Regulatory labelLupron Depot prescribing informationCurrent DailyMed prostate-cancer depot label with product-specific intervals and warnings.
Products + regulatory context
Same ingredient. Different records.
| Product | Form | Profile scope | Record |
|---|---|---|---|
| Lupron Depot | Intramuscular depot | Product-line indications include prostate cancer and selected gynecologic uses. | [1]Regulatory labelLupron Depot prescribing informationCurrent DailyMed prostate-cancer depot label with product-specific intervals and warnings. |
| Eligard | Subcutaneous depot | Advanced prostate cancer. | [25]Published evidence snapshotThese highlights do not include all the information needed to use ELIGARD®safely and effectively. See full prescribing information for ELIGARD®.ELIGARD®(leuprolide acetate) for injectable suspension, for subcutaneous useInitial U.S. Approval: 2002dailymed · T1 |
| Fensolvi | Subcutaneous depot | Central precocious puberty. | [13]Published evidence snapshotThese highlights do not include all the information needed to use FENSOLVI®safely and effectively. See full prescribing information for FENSOLVI.FENSOLVI (leuprolide acetate) for injectable suspension, for subcutaneous useInitial U.S. Approval: 1985dailymed · T1 |
| Camcevi | Subcutaneous depot | Advanced prostate cancer. | [21]Published evidence snapshotThese highlights do not include all the information needed to use CAMCEVI™ safely and effectively. See full prescribing information for CAMCEVI.CAMCEVI (leuprolide) injectable emulsion, for subcutaneous useInitial U.S. Approval: 2021dailymed · T1 |
Do not infer dosing, interchangeability, or an approved use from the ingredient name alone. Open the current label for the exact product and presentation.
Administration, interactions + monitoring
The practical clinical context.
- Administration boundary
- Healthcare-administered depot injection at product-specific intervals; strengths are not interchangeable solely by milligram amount. [1]Regulatory labelLupron Depot prescribing informationCurrent DailyMed prostate-cancer depot label with product-specific intervals and warnings.
Research status + gaps
What still needs better answers.
1212 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (690), assurance_score_below_0.72 (421), current_regulatory_source_required (250), evidence_scope (311), extraction_ambiguity (825), extraction_confidence_not_high (3), high_risk_requires_regulatory_or_two_independent_sources (480), no_direct_support (1096), proposal_not_staged (30)
How Peplexicon reads evidence
- Authority
- What kind of source is making the statement?
- Independence
- Do multiple citations represent separate studies—or the same evidence repeated?
- Directness
- Does the population, product, dose, outcome, and time horizon match the claim?
- Consistency
- Do credible sources support, qualify, or contradict one another?
References + discovery
Open the records yourself.
- 1Regulatory labelLupron Depot prescribing informationOpen ↗
Current DailyMed prostate-cancer depot label with product-specific intervals and warnings.
- 2Literature indexEvery PubMed result for leuprolideOpen ↗
Live National Library of Medicine literature search; results are not pre-screened or deduplicated.
- 3Trial registryEvery registered study for leuprolideOpen ↗
Live ClinicalTrials.gov search, including completed, active, and historical records.
- 4Chemical recordleuprolide chemical recordOpen ↗
PubChem compound search from the National Library of Medicine.
- 5Published evidence snapshotChEMBL activities for CHEMBL1201199Open ↗
chembl-activities · T6
Published 2026-08-21 · retrieved 2026-08-21T17:03:42Z - 6Published evidence snapshotLEUPROLIDEOpen ↗
chembl-molecule · T6
Published 2026-08-21 · retrieved 2026-08-21T17:03:42Z - 7Published evidence snapshotThese highlights do not include all the information needed to use VABRINTY™ safely and effectively. See full prescribing information for VABRINTY.VABRINTY (leuprolide acetate) for injectable suspension, for subcutaneous useInitial U.S. Approval: 2002Open ↗
dailymed · T1
Published 2026-04-30 · retrieved 2026-08-21T17:03:42Z - 8Published evidence snapshotThese highlights do not include all the information needed to use LUPRON DEPOT3.75mg safely and effectively. See full prescribing information for LUPRON DEPOT3.75mg.LUPRON DEPOT3.75mg (leuprolide acetate for depot suspension) for injection, for intramuscular useInitial U.S. Approval: 1985Open ↗
dailymed · T1
Published 2025-09-18 · retrieved 2026-08-18T22:04:23Z - 9Published evidence snapshotLeuprolide Acetate InjectionRx onlyOpen ↗
dailymed · T1
Published 2025-06-24 · retrieved 2026-09-01T08:37:10Z - 10Published evidence snapshotThese highlights do not include all the information needed to use LEUPROLIDE ACETATE FOR DEPOT SUSPENSION safely and effectively. See full prescribing information for LEUPROLIDE ACETATE FOR DEPOT SUSPENSION.LEUPROLIDE ACETATE FOR DEPOT SUSPENSION.Initial U.S. Approval: 2018Open ↗
dailymed · T1
Published 2024-08-27 · retrieved 2026-08-18T22:04:17Z - 11Published evidence snapshotLeuprolide Acetate Injection(leuprolide acetate)Rx onlyOpen ↗
dailymed · T1
Published 2026-01-16 · retrieved 2026-09-01T08:37:10Z - 12Published evidence snapshotLeuprolide Acetate INJECTION(leuprolide acetate)Open ↗
dailymed · T1
Published 2024-06-10 · retrieved 2026-08-21T17:03:42Z - 13Published evidence snapshotThese highlights do not include all the information needed to use FENSOLVI®safely and effectively. See full prescribing information for FENSOLVI.FENSOLVI (leuprolide acetate) for injectable suspension, for subcutaneous useInitial U.S. Approval: 1985Open ↗
dailymed · T1
Published 2025-09-25 · retrieved 2026-09-05T08:43:42Z - 14Published evidence snapshotLUPRON®INJECTION(leuprolide acetate)Open ↗
dailymed · T1
Published 2008-02-29 · retrieved 2026-08-18T22:04:27Z - 15Published evidence snapshotLeuprolide Acetate InjectionRx onlyOpen ↗
dailymed · T1
Published 2026-05-25 · retrieved 2026-08-25T08:39:52Z - 16Published evidence snapshotThese highlights do not include all the information needed to use LUTRATE DEPOT safely and effectively. See full prescribing information for LUTRATE DEPOT.LUTRATE®DEPOT (leuprolide acetate), for depot suspensionInitial U.S. Approval: 2018Open ↗
dailymed · T1
Published 2025-06-03 · retrieved 2026-09-05T08:43:42Z - 17Published evidence snapshotLeuprolide Acetate Injection[14 mg/2.8 mL (1 mg/0.2 mL)]Rx onlyOpen ↗
dailymed · T1
Published 2026-05-28 · retrieved 2026-08-21T17:03:42Z - 18Published evidence snapshotLeuprolide Acetate InjectionRx onlyOpen ↗
dailymed · T1
Published 2026-05-08 · retrieved 2026-08-25T08:39:52Z - 19Published evidence snapshotLeuprolide Acetate InjectionRx onlyOpen ↗
dailymed · T1
Published 2026-02-09 · retrieved 2026-09-01T08:37:10Z - 20Published evidence snapshotThese highlights do not include all the information needed to use LUPRON DEPOT 11.25 mg safely and effectively. See full prescribing information for LUPRON DEPOT 11.25 mg.LUPRON DEPOT 11.25 mg (leuprolide acetate for depot suspension)for injection, for intramuscular useInitial U.S. Approval: 1985Open ↗
dailymed · T1
Published 2025-09-10 · retrieved 2026-09-05T08:43:42Z - 21Published evidence snapshotThese highlights do not include all the information needed to use CAMCEVI™ safely and effectively. See full prescribing information for CAMCEVI.CAMCEVI (leuprolide) injectable emulsion, for subcutaneous useInitial U.S. Approval: 2021Open ↗
dailymed · T1
Published 2021-11-15 · retrieved 2026-09-09T08:36:24Z - 22Published evidence snapshotViadur®(leuprolide acetate implant)Open ↗
dailymed · T1
Published 2006-05-10 · retrieved 2026-09-09T08:36:24Z - 23Published evidence snapshotLeuprolide Acetate InjectionRx OnlyOpen ↗
dailymed · T1
Published 2026-05-19 · retrieved 2026-08-25T08:39:52Z - 24Published evidence snapshotLeuprolide Acetate InjectionRx onlyOpen ↗
dailymed · T1
Published 2026-04-24 · retrieved 2026-08-18T22:04:25Z - 25Published evidence snapshotThese highlights do not include all the information needed to use ELIGARD®safely and effectively. See full prescribing information for ELIGARD®.ELIGARD®(leuprolide acetate) for injectable suspension, for subcutaneous useInitial U.S. Approval: 2002Open ↗
dailymed · T1
Published 2019-04-29 · retrieved 2026-09-09T08:36:24Z - 26Published evidence snapshotThese highlights do not include all the information needed to use ELIGARD®safely and effectively. See full prescribing information for ELIGARD.ELIGARD (leuprolide acetate) for injectable suspension, for subcutaneous useInitial U.S. Approval: 2002Open ↗
dailymed · T1
Published 2026-04-30 · retrieved 2026-08-28T12:18:09Z - 27Published evidence snapshotLeuprolide Acetate InjectionRx onlyOpen ↗
dailymed · T1
Published 2025-11-21 · retrieved 2026-09-01T08:37:10Z - 28Published evidence snapshotThese highlights do not include all the information needed to use LUPRON DEPOT safely and effectively. See full prescribing information for LUPRON DEPOT.LUPRON DEPOT®(leuprolide acetate for depot suspension)Initial U.S. Approval: 1989Open ↗
dailymed · T1
Published 2026-03-15 · retrieved 2026-08-18T22:04:21Z - 29Published evidence snapshotThese highlights do not include all the information needed to use CAMCEVI®safely and effectively. See full prescribing information for CAMCEVI.CAMCEVI (leuprolide) injectable emulsion, for subcutaneous useInitial U.S. Approval: 2021Open ↗
dailymed · T1
Published 2026-02-18 · retrieved 2026-08-28T12:18:09Z - 30Published evidence snapshotLeuprolide Acetate Injection(leuprolide acetate)Rx onlyOpen ↗
dailymed · T1
Published 2026-03-29 · retrieved 2026-08-28T12:18:09Z - 31Published evidence snapshotLeuprolide Acetate InjectionOpen ↗
dailymed · T1
Published 2026-04-23 · retrieved 2026-08-25T08:39:52Z - 32Published evidence snapshotThese highlights do not include all the information needed to use CAMCEVI®safely and effectively. See full prescribing information for CAMCEVI.CAMCEVI (leuprolide) injectable emulsion, for subcutaneous useInitial U.S. Approval: 2021Open ↗
dailymed · T1
Published 2026-02-18 · retrieved 2026-08-28T12:18:09Z - 33Published evidence snapshotThese highlights do not include all the information needed to use FENSOLVI®safely and effectively. See full prescribing information for FENSOLVI.FENSOLVI (leuprolide acetate) for injectable suspension, for subcutaneous useInitial U.S. Approval: 1985Open ↗
dailymed · T1
Published 2022-04-28 · retrieved 2026-09-09T08:36:24Z - 34Published evidence snapshotThese highlights do not include all the information needed to use LUPRON DEPOT-PED safely and effectively. See full prescribing information for LUPRON DEPOT-PED.LUPRON DEPOT-PED®(leuprolide acetate for depot suspension),for intramuscular useInitial U.S. Approval:1985Open ↗
dailymed · T1
Published 2025-11-14 · retrieved 2026-08-25T11:03:06Z - 35Published evidence snapshotEvaluation of the pharmacokinetics and pharmacodynamics of two leuprolide acetate 45 mg 6‐month depot formulations in patients with prostate cancerOpen ↗
doi · T6
Published 2014-05-09 · retrieved 2026-09-08T21:46:05Z - 36Published evidence snapshotOral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer.Open ↗
doi · T2
Published 2020-05-29 · retrieved 2026-09-09T18:01:32Z - 37Published evidence snapshotCardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized TrialOpen ↗
doi · T6
Published 2021-10-19 · retrieved 2026-09-04T19:33:10Z - 38Published evidence snapshotPhase III efficacy and safety trial of a new leuprolide acetate 3.75 mg depot formulation in prostate cancer patientsOpen ↗
doi · T6
Published 2009-05-20 · retrieved 2026-09-08T21:46:06Z - 39Published evidence snapshotIUPHAR ligand commentaryOpen ↗
iuphar-comments · T6
Published 2026-08-21 · retrieved 2026-08-21T17:03:42Z - 40Published evidence snapshotleuprolideOpen ↗
iuphar-ligand · T6
Published 2026-08-21 · retrieved 2026-08-21T17:03:42Z - 41Published evidence snapshotClinical pharmacokinetics of depot leuprorelin.Open ↗
pubmed · T3
Published 2002-01-01 · retrieved 2026-08-25T11:03:06Z - 42Published evidence snapshotLeuprorelin. A review of its pharmacology and therapeutic use in prostatic disorders.Open ↗
pubmed · T3
Published 1991-01-01 · retrieved 2026-09-08T21:46:08Z - 43Published evidence snapshotLeuprolide acetate: a drug of diverse clinical applications.Open ↗
pubmed · T3
Published 2007-11-01 · retrieved 2026-09-09T18:01:33Z - 44Published evidence snapshotLupron depot (leuprolide acetate for depot suspension) in the treatment of endometriosis: a randomized, placebo-controlled, double-blind study. Lupron Study Group.Open ↗
pubmed · T2
Published 1990-09-01 · retrieved 2026-09-09T22:10:07Z - 45Published evidence snapshotEfficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer.Open ↗
pubmed · T3
Published 2012-03-01 · retrieved 2026-09-08T21:46:07Z - 46Published evidence snapshotEfficacy of Different Leuprolide Administration Schedules in Premenopausal Breast Cancer: A Retrospective Review.Open ↗
pubmed · T3
Published 2018-10-01 · retrieved 2026-09-09T22:10:08Z - 47Published evidence snapshotpubmed-31869126Open ↗
pubmed · T3
Published 2026-08-17 · retrieved 2026-08-17T23:10:15Z - 48Published evidence snapshotFixed Dosing of Leuprolide Acetate, a GnRH Agonist, in Children with Central Precocious Puberty: A Population Pharmacokinetic Justification.Open ↗
pubmed · T2
Published 2026-05-01 · retrieved 2026-08-25T08:39:52Z - 49Published evidence snapshotLeuprolide Acetate Promotes Sensory Recovery and Modulates Dorsal Root Ganglion Responses After Sciatic Nerve Transection in Rats.Open ↗
pubmed · T3
Published 2026-03-20 · retrieved 2026-08-25T08:39:52Z - 50Published evidence snapshotMicrofluidic Engineering of Core-Shell PLGA Microspheres with Adjustable Shell Thickness for Long-Acting Delivery of Leuprolide Acetate.Open ↗
pubmed · T3
Published 2026-05-05 · retrieved 2026-08-21T17:03:42Z - 51Published evidence snapshotPreliminary Evaluation of Leuprorelin Acetate Microspheres Plus Levonorgestrel-Releasing Intrauterine System in Endometriosis: An Exploratory Study Focusing on BNIP3 and EPAC1 Expression.Open ↗
pubmed · T3
Published 2026-05-01 · retrieved 2026-08-21T17:03:42Z - 52Published evidence snapshotSurpassing genetic height potential at final adult height after monthly depot leuprolide therapy in Taiwanese girls with central precocious or early puberty: a ROC-based analysis.Open ↗
pubmed · T3
Published 2026-01-01 · retrieved 2026-08-25T08:39:52Z - 53Published evidence snapshotGnRH Agonists and Antagonists in IVF/ICSI Cycles of PCOS Women: A Network Meta-Analysis.Open ↗
pubmed · T2
Published 2026-05-01 · retrieved 2026-08-21T17:03:42Z - 54Published evidence snapshotFailure of a LHRH agonist in metastatic prostate cancer: a case report and review of literature.Open ↗
pubmed · T3
Published 2026-05-20 · retrieved 2026-08-21T17:03:42Z - 55Published evidence snapshotUtility of a 40-minute LH level after depot leuprolide for diagnosis and treatment monitoring in girls with CPP.Open ↗
pubmed · T2
Published 2026-09-01 · retrieved 2026-09-05T08:43:42Z - 56Published evidence snapshotpubmed-42299119Open ↗
pubmed · T3
Published 2026-08-17 · retrieved 2026-08-17T23:10:15Z - 57Published evidence snapshotpubmed-42338704Open ↗
pubmed · T3
Published 2026-08-17 · retrieved 2026-08-17T23:10:15Z - 58Published evidence snapshotTherapeutic efficacy of leuprorelin acetate combined with rhGH in girls with ICPP and Its impact on body height and secondary sexual characteristics.Open ↗
pubmed · T3
Published 2026-06-01 · retrieved 2026-08-21T17:03:42Z - 59Published evidence snapshotpubmed-42415823Open ↗
pubmed · T3
Published 2026-08-17 · retrieved 2026-08-17T23:10:15Z - 60Published evidence snapshotpubmed-42427703Open ↗
pubmed · T3
Published 2026-08-17 · retrieved 2026-08-17T23:10:15Z - 61Published evidence snapshotpubmed-42469731Open ↗
pubmed · T3
Published 2026-08-17 · retrieved 2026-08-17T23:10:15Z - 62Published evidence snapshotpubmed-42529459Open ↗
pubmed · T3
Published 2026-08-17 · retrieved 2026-08-17T23:10:15Z - 63Published evidence snapshotpubmed-42591741Open ↗
pubmed · T3
Published 2026-08-17 · retrieved 2026-08-17T23:10:15Z - 64Published evidence snapshotEfficacy and safety of goserelin vs. leuprolide in premenopausal breast cancer patients receiving adjuvant endocrine therapy: A retrospective cohort study.Open ↗
pubmed · T3
Published 2026-08-19 · retrieved 2026-08-21T17:03:42Z - 65Published evidence snapshotMeningioma enlargement associated with luteinizing hormone-releasing hormone agonist therapy: two cases and supporting in vitro evidence.Open ↗
pubmed · T3
Published 2026-09-05 · retrieved 2026-09-09T08:36:24Z - 66Published evidence snapshotLeuprorelin. A review of its pharmacology and therapeutic use in prostatic cancer, endometriosis and other sex hormone-related disorders.Open ↗
pubmed · T3
Published 1994-12-01 · retrieved 2026-09-09T18:01:33Z