189 completed, 41 unknown, 40 active not recruiting, 36 terminated. 164 Phase 2, 92 Phase 3, 42 Phase 4, 30 Phase 1, 27 Not applicable.
Follow this drug Literature Review of Leuprolide trials Research Report on Leuprolide
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant Chemotherapy Iparomlimab and Tuvonralimab (QL1706), Aromatase Inhibitor (AI), CDK4/6 inhibitor - Breast Cancer | Phase 2 | Not yet recruiting | Hebei Medical University Fourth Hospital | 40 | 2026-10-01 | 2026-08-26 |
| Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast Cancer NaCET: For chemotherapy, the TEC or EC-T regimen is selected; for endocrine therapy, letrozole is administered; for premenopausal patients, an LHRH agonist-goserelin or leuprolide - Invasive Breast Cancer (Stage I-III) | Phase 2 | Not yet recruiting | The Second Hospital of Anhui Medical University | 36 | 2026-09-30 | 2026-09-03 |
| BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder Aromatase Inhibitors, Bupropion, GnRH agonist - Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder | Phase 1 / Phase 2 | Not yet recruiting | University of Illinois at Chicago | 100 | 2026-09-01 | 2026-08-24 |
| A Phase Ia Trial Comparing the Pharmacokinetics/Pharmacodynamics, Safety, and Preliminary Efficacy of HHK001 and Enantone in Patients With Endometriosis HHK001 (Leuprorelin Acetate Microspheres for Injection), Enantone (Leuprorelin Acetate Microspheres for Injection) - Endometriosis | Phase 1 | Not yet recruiting | The Third Xiangya Hospital of Central South University | 20 | 2026-08-31 | 2026-08-28 |
| Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis Leuprorelin Acetate, Leuprorelin Acetate 3.75mg Injection - Endometriosis | Phase 1 | Recruiting | Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd. | 30 | 2026-08-31 | 2026-09-02 |
| Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer Abiraterone, Apalutamide, Enzalutamide or Darolutamide (ARPI therapy) (per standard of care) therapy - Prostate Cancer, mHSPC | Phase 3 | Recruiting | University College, London | 1500 | 2026-08-28 | 2026-10-16 |
| Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate Cancer Androgen Deprivation Therapy (ADT), Radiotherapy - Prostate Cancer | Phase 2 | Recruiting | NYU Langone Health | 90 | 2026-08-06 | 2026-09-03 |
| Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial Abiraterone Acetate, Biospecimen Collection, Leuprolide Acetate - Recurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 | Phase 2 | Recruiting | Mayo Clinic | 202 | 2026-08-04 | 2026-09-18 |
| Autonomic and Renal Contributions to Hypertension With ADT Gonadotropin Releasing Hormone Agonists (GNRH), Androgen receptor (AR) inhibitor, Placebo - Androgen Deprivation Therapy, Prostate Cancer | Phase 4 | Recruiting | Virginia Commonwealth University | 50 | 2026-08-01 | 2026-09-30 |
| A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty Leuprorelin - Central Precocious Puberty | Phase 4 | Recruiting | LG Chem | 43 | 2026-08-01 | 2026-07-29 |
| Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT Leuprolide, Degarelix, Relugolix - Prostate Cancer, Localized Prostate Carcinoma | Phase 2 | Recruiting | Baptist Health South Florida | 50 | 2026-07-29 | 2026-08-06 |
| Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer Darolutamide, Pembrolizumab, Lupron - Prostate Cancer, High-risk Prostate Cancer | Phase 2 | Recruiting | Icahn School of Medicine at Mount Sinai | 40 | 2026-05-21 | 2026-10-07 |
| Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response Testosterone cypionate, Luteinizing hormone-releasing hormone (LHRH) analogue, Darolutamide - Metastatic Castration-resistant Prostate Cancer | Phase 2 | Recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 60 | 2026-03-09 | 2026-03-11 |
| Rezvilutamide for High-Risk Prostate Cancer After Surgery Rezvilutamide and Leuprorelin - Prostate Cancer (Adenocarcinoma) | Not applicable | Not yet recruiting | Fujian Medical University Union Hospital | 33 | 2026-02-11 | 2026-03-03 |
| Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial Biospecimen Collection, Electronic Health Record Review, Goserelin - Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8 | Phase 2 | Recruiting | University of Michigan Rogel Cancer Center | 75 | 2026-01-22 | 2026-06-23 |
| A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer Elacestrant, Leuprorelin - Breast Cancer | Phase 2 | Recruiting | Gustave Roussy, Cancer Campus, Grand Paris | 140 | 2025-10-06 | 2025-12-01 |
| Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study Trastuzumab rezetecan, Pyrotinib, Dalpiciclib - HER2-positive Breast Cancer | Phase 2 | Not yet recruiting | Fudan University | 288 | 2025-09-10 | 2025-09-18 |
| The COSMYC Trial (COmbined Suppression of MYC) ZEN-3694, Testosterone cypionate, Enzalutamide - Metastatic Castration-resistant Prostate Cancer | Phase 2 | Recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 50 | 2025-08-19 | 2026-06-18 |
| A Clinical Study of KLH-2109 in Patients With Endometriosis KLH-2109, Leuprorelin acetate - Endometriosis | Phase 3 | Active not recruiting | Kissei Pharmaceutical Co., Ltd. | 288 | 2025-06-09 | 2026-03-02 |
| Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer Gonadotropin Releasing Hormone Agonists and Antagonists, Bicalutamide, Biopsy Procedure - High Risk Prostate Carcinoma, Localized Prostate Adenocarcinoma | Phase 2 | Withdrawn | OHSU Knight Cancer Institute | 2025-04-16 | 2025-09-23 |
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Prostatic Neoplasms (189) · Breast Neoplasms (28) · Endometriosis (21) · Puberty, Precocious (17) · Neoplasms (13) · Infertility (11) · Leiomyoma (11) · Rare Diseases (7) · Obesity (6) · Endocrine System Diseases (5) · Neoplasm Metastasis (5) · Polycystic Ovary Syndrome (5) · Hypertension (4) · Hypogonadism (4) · Adenocarcinoma (3)
Takeda (15) · M.D. Anderson Cancer Center (13) · National Cancer Institute (NCI) (9) · Dana-Farber Cancer Institute (8) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (8) · Abbott (7) · Mayo Clinic (7) · University of Colorado, Denver (7) · Fudan University (6) · Memorial Sloan Kettering Cancer Center (6) · University of Washington (6) · Ferring Pharmaceuticals (5) · Radiation Therapy Oncology Group (5) · Alliance for Clinical Trials in Oncology (4) · Massachusetts General Hospital (4)
United States (217) · Canada (39) · China (25) · France (19) · Italy (19) · Japan (17) · Germany (16) · South Korea (16) · Netherlands (15) · United Kingdom (15) · Belgium (13) · Spain (13) · Poland (12) · Czechia (10) · Taiwan (10)
Christopher Logothetis (3) · Fulvio Zullo, MD,PhD (3) · Mary-Ellen Taplin, MD (3) · Samuel Denmeade, MD (3) · Carlos Vargas, MD (2) · Celestia Higano, MD (2) · Jingsong Zhang, MD, PhD (2)
PMID 34350976, PMID 38421243, PMID 38421252, PMID 20818327, PMID 38320143, PMID 39074346, PMID 10663329, PMID 12372443, PMID 15315996, PMID 17194907, PMID 17405995, PMID 17405996, PMID 18037582, PMID 18077826, PMID 18172212, PMID 18212313, PMID 18291508, PMID 18309951, PMID 18647805, PMID 18989865, PMID 19012911, PMID 19017549, PMID 19035858, PMID 19167733, PMID 19171333, PMID 19395184, PMID 19395186, PMID 19858385, PMID 19864082, PMID 19957321, PMID 19963436, PMID 20435244, PMID 21123449, PMID 21518701, PMID 21601197, PMID 21751904, PMID 21860633, PMID 22006050, PMID 22025196, PMID 22056152, PMID 22282904, PMID 22296076, PMID 22344198, PMID 22498212, PMID 22723326, PMID 22931259, PMID 23127770, PMID 23151431, PMID 23798006, PMID 23820515
P30CA015083 (4), U10CA180868 (4), 2016 (3), U10CA031946 (3), U10CA032102 (3), 2005 (2), 2017 (2), 2023 (2), P30CA016672 (2), P30CA033572 (2), P30CA138292 (2), P50HD073063 (2), U10CA180820 (2), 2009 (1), 2014 (1)