Definition and research guide
This page combines a MeSH definition, publication statistics and selected research abstracts. It is a starting point for reading the literature, not a medical textbook or a systematic evidence review.
Content available: 4 complete abstracts (797 words), 10 references. Full article text is not stored or reproduced here; follow the PMID, DOI or PMC links to read the original sources and their access terms.
Definition
A potent synthetic long-acting agonist of gonadotropin-releasing hormone that regulates the synthesis and release of pituitary gonadotropins, luteinizing hormone and follicle stimulating hormone.
Definition: NLM Medical Subject Headings (MeSH) scope note (Public domain (U.S. National Library of Medicine); attribution requested). View the MeSH record.
Also known as: Leuprorelin; TAP-144; TAP144; TAP 144; Enantone; Leuprolide, (L-Leu)-Isomer; Leuprolide, (DL-Leu)-Isomer; Leuprolide Monoacetate.
Where it fits in the MeSH classification
- Broader topics
- Gonadotropin-Releasing Hormone
Related concepts
Research landscape
PubMed indexes 3,200 records tagged with the MeSH heading “Leuprolide” (counts retrieved 2026-10-31). 298 of them (9.3%) were published from 2020 onward, and the busiest period so far is through 1999 with 1,195 records.
Reviews account for 263 records (8.2%) and meta-analyses for 21. Randomized controlled trials number 509 (15.9%) as a share of all records on the topic. Randomized trials make up a comparatively large share of this literature, which means many treatment questions have been tested directly.
Show the data
| Period | Records |
|---|---|
| through 1999 | 1,195 |
| 2000-2009 | 981 |
| 2010-2019 | 726 |
| 2020 onward | 298 |
Publication-type chart data
| Type | Records | Share |
|---|---|---|
| Reviews | 263 | 8.2% |
| Meta-analyses | 21 | 0.7% |
| Randomized controlled trials | 509 | 15.9% |
Method: PubMed query "Leuprolide"[MeSH Terms] with publication-type and date filters, retrieved 2026-10-31.
Reading the evidence in drugs and chemicals
Studies of a chemical or drug can answer very different questions: what it is and how it behaves in cells and animals, how the body handles it, and whether it changes outcomes in people. Laboratory and animal findings often do not carry over to patients, and observational studies of exposures are confounded by who uses a substance and why. Nothing on this page is a recommendation to use, avoid, start or stop any substance or medicine; talk to a qualified clinician or pharmacist about your own situation. Check the dose, the species, the comparison group and whether a patient-relevant outcome was measured.
Evidence from open-access studies
These open-access studies come from PubMed’s best-match results for this heading (papers whose main topic it is), ranked here by citation count, with one recent addition. Each abstract is reproduced in full under its recorded open licence so that you can read the authors’ own words. They illustrate the literature; they are not a systematic summary of it. Citation counts measure attention, not reliability or clinical benefit.
Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment [1]
Abstract reading summary — source excerpts
- Opening excerpt
- ImportanceWith a growing interest in the use of real-world evidence for regulatory decision-making, it is important to understand whether real-world data can be used to emulate the results of randomized clinical trials.
- Closing excerpt
- Comparison of these data with PRONOUNCE trial results, when published, will help enhance our understanding of the appropriate role of using real-world data to emulate clinical trials.
- Interpretation limits
- Verbatim excerpts from the authors’ abstract; the closing excerpt may describe a finding, limitation or recommendation. Design, population, effect size and uncertainty have not been independently extracted or appraised. Read the complete abstract and linked paper before interpreting the findings.
Read complete abstract (375 words)
ImportanceWith a growing interest in the use of real-world evidence for regulatory decision-making, it is important to understand whether real-world data can be used to emulate the results of randomized clinical trials.ObjectiveTo use electronic health record and administrative claims data to emulate the ongoing PRONOUNCE trial (A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease).Design, setting, and participantsThis retrospective, propensity-matched cohort study included adult men with a diagnosis of prostate cancer and cardiovascular disease who initiated either degarelix or leuprolide between December 24, 2008, and June 30, 2019. Participants were commercially insured individuals and Medicare Advantage beneficiaries included in a large US administrative claims database.ExposuresDegarelix or leuprolide.Main outcomes and measuresThe primary end point was time to first occurrence of a major adverse cardiovascular event (MACE), defined as death due to any cause, myocardial infarction, or stroke, analogous to the PRONOUNCE trial. Secondary end points were time to death due to any cause, myocardial infarction, stroke, and angina. Cox proportional hazards regression was used to evaluate primary and secondary end points.ResultsA total of 32 172 men initiated degarelix or leuprolide for prostate cancer; of them, 9490 (29.5%) had cardiovascular disease, and 7800 (24.2%) met the PRONOUNCE trial eligibility criteria and were included in this study. Overall, 165 participants (2.1%) were Asian, 1390 (17.8%) were Black, 663 (8.5%) were Hispanic, and 5258 (67.4%) were White. The mean (SD) age was 74.4 (7.4) years. Among 2226 propensity score-matched patients, no significant difference was observed in the risk of MACE for patients taking degarelix vs those taking leuprolide (10.18 vs 8.60 events per 100 person-years; hazard ratio [HR], 1.18; 95% CI, 0.86-1.61). Degarelix was associated with a higher risk of death from any cause (HR, 1.48; 95% CI, 1.01-2.18) but not of myocardial infarction (HR, 1.16; 95% CI, 0.60-2.25), stroke (HR, 0.92; 95% CI, 0.45-1.85), or angina (HR, 1.36; 95% CI, 0.43-4.27).Conclusions and relevanceIn this emulation of a clinical trial of men with cardiovascular disease undergoing treatment for prostate cancer, degarelix was not associated with a lower risk of cardiovascular events than leuprolide. Comparison of these data with PRONOUNCE trial results, when published, will help enhance our understanding of the appropriate role of using real-world data to emulate clinical trials.
Abstract reproduced from the open-access article under the recorded cc by licence; © the authors. PMID 34677594 · DOI · PMC8536955
Phase 3 Trial of a Small-volume Subcutaneous 6-Month Duration Leuprolide Acetate Treatment for Central Precocious Puberty [2]
Abstract reading summary — source excerpts
- Opening excerpt
- ContextGonadotropin-releasing hormone agonists (GnRHas) are standard of care for central precocious puberty (CPP).
- Closing excerpt
- This long-acting GnRHa preparation of leuprolide acetate is a new, effective, and well-tolerated therapy for children with CPP.
- Interpretation limits
- Verbatim excerpts from the authors’ abstract; the closing excerpt may describe a finding, limitation or recommendation. Design, population, effect size and uncertainty have not been independently extracted or appraised. Read the complete abstract and linked paper before interpreting the findings.
Read complete abstract (141 words)
ContextGonadotropin-releasing hormone agonists (GnRHas) are standard of care for central precocious puberty (CPP). A 6-month subcutaneous injection has recently been approved by the Food and Drug Administration.ObjectiveDetermine efficacy, pharmacokinetics, and safety of 6-month 45-mg subcutaneous leuprolide acetate for CPP.DesignPhase 3 multicenter, open-label, single-arm study.Setting25 sites in 6 countries.Subjects64 GnRHa-naïve children with CPP (age: 7.5 ± 0.1 years) received study drug: 59 completed the study.Intervention(s)2 doses of 45-mg subcutaneous leuprolide acetate (0.375 mL) at 0 and 24 weeks; children were followed for 48 weeks.Main outcome measure(s)Percentage of children with serum luteinizing hormone (LH) Results54/62 (87%) children achieved poststimulation LH ConclusionsA small volume of 45-mg subcutaneous leuprolide acetate administered at a 6-month interval effectively suppressed pubertal hormones and stopped or caused regression of pubertal progression. This long-acting GnRHa preparation of leuprolide acetate is a new, effective, and well-tolerated therapy for children with CPP.
Abstract reproduced from the open-access article under the recorded cc by licence; © the authors. PMID 32738042 · DOI · PMC7442270
Androgen deprivation therapy in castrate-resistant prostate cancer: how important is GnRH agonist backbone therapy? [3]
Abstract reading summary — source excerpts
- Opening excerpt
- BackgroundA growing number of treatment options exist to treat metastatic castrate-resistant prostate cancer (mCRPC), and with these newer options, many questions about optimising treatment remain unanswered.
- Closing excerpt
- OutcomeThis statement, reflecting the views of the authors, provides a discussion of this evidence and the rationale behind the recommendation that ADT should be continued in CRPC.
- Interpretation limits
- Verbatim excerpts from the authors’ abstract; the closing excerpt may describe a finding, limitation or recommendation. Design, population, effect size and uncertainty have not been independently extracted or appraised. Read the complete abstract and linked paper before interpreting the findings.
Read complete abstract (102 words)
BackgroundA growing number of treatment options exist to treat metastatic castrate-resistant prostate cancer (mCRPC), and with these newer options, many questions about optimising treatment remain unanswered. One recommendation that may potentially be overlooked by practitioners is that androgen deprivation therapy (ADT) should be maintained when CRPC develops and when treatment with any of the newer agents is initiated.AimHowever, to emphasise this recommendation, it is valuable to interrogate the evidence for maintaining ADT in different clinical situations.OutcomeThis statement, reflecting the views of the authors, provides a discussion of this evidence and the rationale behind the recommendation that ADT should be continued in CRPC.
Abstract reproduced from the open-access article under the recorded cc by licence; © the authors. PMID 25261259 · DOI · PMC4512260
Effectiveness of leuprolide acetate administered monthly compared to three-monthly in the treatment of central precocious puberty: evaluation at the end of treatment [4]
Abstract reading summary — source excerpts
- Opening excerpt
- IntroductionGonadotropin-releasing hormone (GnRH) analogs are the standard treatment for central precocious puberty (CPP).
- Closing excerpt
- ConclusionThe 3-monthly treatment showed greater hormonal and growth suppression effects, but there was no significant difference in PAH between the two groups.
- Interpretation limits
- Verbatim excerpts from the authors’ abstract; the closing excerpt may describe a finding, limitation or recommendation. Design, population, effect size and uncertainty have not been independently extracted or appraised. Read the complete abstract and linked paper before interpreting the findings.
Read complete abstract (179 words)
IntroductionGonadotropin-releasing hormone (GnRH) analogs are the standard treatment for central precocious puberty (CPP). Although there are numerous varieties of GnRH agonists, the effectiveness of 1-monthly compared with 3-monthly Leuprolide acetate is still restricted. The objective of this study was to evaluate the outcomes of CPP treatment with Leuprolide acetate at a 1-monthly dosage of 3.75 mg, in comparison to a dosage of 11.25 mg administered every 3 months.MethodThis retrospective cohort study involved 143 girls diagnosed with CPP with 72 of them receiving the monthly treatment regimen and 71 receiving the 3-monthly treatment regimen. Anthropometric measurements were compared at the start and end of the therapy. The rates and level of LH suppression were assessed six months after therapy.ResultsThe regimen administered every 3 months showed more significant suppression of LH. The 3-monthly group showed lower actual height and degree of bone age advancement at the end of therapy. However, the predicted adult height (PAH) remained comparable in both groups.ConclusionThe 3-monthly treatment showed greater hormonal and growth suppression effects, but there was no significant difference in PAH between the two groups.
Abstract reproduced from the open-access article under the recorded cc by licence; © the authors. PMID 38737553 · DOI · PMC11084664
Key reviews and meta-analyses
The most cited review-type papers among PubMed’s best-match results for this heading, listed with bibliographic details only. Follow the links for the full text and access terms.
- Research article Leuprolide acetate: a drug of diverse clinical applications [5]
- Research article Clinical pharmacokinetics of depot leuprorelin [6]
- Research article Leuprorelin. A review of its pharmacology and therapeutic use in prostatic cancer, endometriosis and other sex hormone-related disorders [7]
- Research article MANAGEMENT OF ENDOCRINE DISEASE: Long-term outcomes of the treatment of central precocious puberty [8]
- Research article Gonadotropin-releasing hormone: an update review of the antagonists versus agonists [9]
- Research article Long-acting injectable PLGA/PLA depots for leuprolide acetate: successful translation from bench to clinic [10]
References
- Wallach JD, Deng Y, McCoy RG, Dhruva SS, Herrin J, Berkowitz A, et al.. Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment. . 2021. PMID 34677594 · DOI · PMC8536955
- Klein KO, Freire A, Gryngarten MG, Kletter GB, Benson M, Miller BS, et al.. Phase 3 Trial of a Small-volume Subcutaneous 6-Month Duration Leuprolide Acetate Treatment for Central Precocious Puberty. . 2020. PMID 32738042 · DOI · PMC7442270
- Merseburger AS, Hammerer P, Rozet F, Roumeguère T, Caffo O, da Silva FC, et al.. Androgen deprivation therapy in castrate-resistant prostate cancer: how important is GnRH agonist backbone therapy?. . 2015. PMID 25261259 · DOI · PMC4512260
- Thaneetrakool T, Aroonparkmongkol S, Numsriskulrat N, Supornsilchai V, Wacharasindhu S, Srilanchakon K. Effectiveness of leuprolide acetate administered monthly compared to three-monthly in the treatment of central precocious puberty: evaluation at the end of treatment. . 2024. PMID 38737553 · DOI · PMC11084664
- Wilson AC, Meethal SV, Bowen RL, Atwood CS. Leuprolide acetate: a drug of diverse clinical applications. Expert Opin Investig Drugs. 2007. PMID 17970643 · DOI
- Periti P, Mazzei T, Mini E. Clinical pharmacokinetics of depot leuprorelin. Clin Pharmacokinet. 2002. PMID 12083977 · DOI
- Plosker GL, Brogden RN. Leuprorelin. A review of its pharmacology and therapeutic use in prostatic cancer, endometriosis and other sex hormone-related disorders. Drugs. 1994. PMID 7533699 · DOI
- Guaraldi F, Beccuti G, Gori D, Ghizzoni L. MANAGEMENT OF ENDOCRINE DISEASE: Long-term outcomes of the treatment of central precocious puberty. Eur J Endocrinol. 2016. PMID 26466612 · DOI
- Van Poppel H, Klotz L. Gonadotropin-releasing hormone: an update review of the antagonists versus agonists. Int J Urol. 2012. PMID 22416801 · DOI
- Abulateefeh SR. Long-acting injectable PLGA/PLA depots for leuprolide acetate: successful translation from bench to clinic. Drug Deliv Transl Res. 2023. PMID 35976565 · DOI
About this article
- Sources
- NLM Medical Subject Headings (definition, synonyms); NCBI PubMed (counts, identifiers); Europe PMC (open-access abstracts and citation counts).
- Verification
- Every reference was resolved against PubMed on 2026-10-31; title, year and DOI matched.
- Review state
- automated source verified; no human expert review has been recorded yet.
- Version
- 1, last updated 2026-10-31.
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Evidence strength
EvidenceHelix's computed view of the study designs behind this topic: how common meta-analyses, randomized trials and reviews are, how recent the literature is, and a plain-language reading. It describes the design mix of the literature. It is not a quality appraisal of any study, and it is not medical advice.