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Are there clinical trials for Leuprolide?
Leuprolide has 519 registered clinical trials, including 225 completed interventional studies and trials reaching Phase 4. Its use in humans is supported by established registered clinical evidence.
Trial breakdown
By phase
| Phase 2 | 212 |
| Phase 3 | 124 |
| Phase 4 | 59 |
| Phase 1 | 45 |
| Not applicable | 44 |
| Early Phase 1 | 7 |
By status
| Completed | 257 |
| Active, not recruiting | 58 |
| Unknown status | 58 |
| Recruiting | 57 |
| Terminated | 49 |
| Withdrawn | 23 |
| Not yet recruiting | 16 |
| Enrolling by invitation | 1 |
Active trials
- QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant ChemotherapyPhase 2 · Not yet recruiting · 40 participants · Hebei Medical University Fourth Hospital · started 2026-10-01NCT07782840
- Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast CancerPhase 2 · Not yet recruiting · 36 participants · The Second Hospital of Anhui Medical University · started 2026-09-30NCT07801898
- Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With Fulvestrant for the Treatment of Patients With Hormone Receptor Positive (HR+) and HER2 Negative (HER2-) Breast Cancer Extended to Other Organs.Phase 2 · Not yet recruiting · 51 participants · UNICANCER · started 2026-09-18NCT07340619
- BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire DisorderPhase 1 / Phase 2 · Not yet recruiting · 100 participants · University of Illinois at Chicago · started 2026-09NCT07596212
- A Phase Ia Trial Comparing the Pharmacokinetics/Pharmacodynamics, Safety, and Preliminary Efficacy of HHK001 and Enantone in Patients With EndometriosisPhase 1 · Not yet recruiting · 20 participants · The Third Xiangya Hospital of Central South University · started 2026-08-31NCT07793162
- Phase Ia Trial of HHK001 Compared With Enantone in Patients With EndometriosisPhase 1 · Recruiting · 30 participants · Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd. · started 2026-08-31NCT07755956
- Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate CancerPhase 3 · Recruiting · 1500 participants · University College, London · started 2026-08-28NCT07751133
- Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate CancerPhase 2 · Recruiting · 90 participants · NYU Langone Health · started 2026-08-06NCT07801664
Most recent registered trials
- QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant ChemotherapyPhase 2 · Not yet recruiting · 40 participants · Hebei Medical University Fourth Hospital · started 2026-10-01NCT07782840
- Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast CancerPhase 2 · Not yet recruiting · 36 participants · The Second Hospital of Anhui Medical University · started 2026-09-30NCT07801898
- Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With Fulvestrant for the Treatment of Patients With Hormone Receptor Positive (HR+) and HER2 Negative (HER2-) Breast Cancer Extended to Other Organs.Phase 2 · Not yet recruiting · 51 participants · UNICANCER · started 2026-09-18NCT07340619
- BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire DisorderPhase 1 / Phase 2 · Not yet recruiting · 100 participants · University of Illinois at Chicago · started 2026-09NCT07596212
- A Phase Ia Trial Comparing the Pharmacokinetics/Pharmacodynamics, Safety, and Preliminary Efficacy of HHK001 and Enantone in Patients With EndometriosisPhase 1 · Not yet recruiting · 20 participants · The Third Xiangya Hospital of Central South University · started 2026-08-31NCT07793162
- Phase Ia Trial of HHK001 Compared With Enantone in Patients With EndometriosisPhase 1 · Recruiting · 30 participants · Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd. · started 2026-08-31NCT07755956
- Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate CancerPhase 3 · Recruiting · 1500 participants · University College, London · started 2026-08-28NCT07751133
- Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate CancerPhase 2 · Recruiting · 90 participants · NYU Langone Health · started 2026-08-06NCT07801664
- Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE TrialPhase 2 · Recruiting · 202 participants · Mayo Clinic · started 2026-08-04NCT07650240
- Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer.Phase 2 · Not yet recruiting · 200 participants · RenJi Hospital · started 2026-08-01NCT07730151
- Tolerability of Dalpiciclib vs. Abemaciclib/Ribociclib in Early HR+/HER2- Breast CancerNot applicable · Not yet recruiting · 456 participants · Henan Cancer Hospital · started 2026-08-01NCT07706933
- A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious PubertyPhase 4 · Recruiting · 43 participants · LG Chem · started 2026-08-01NCT07710430
Frequently asked questions
Are there clinical trials for Leuprolide?
Leuprolide has 519 registered clinical trials, including 225 completed interventional studies and trials reaching Phase 4. Its use in humans is supported by established registered clinical evidence.
Does a registered trial mean the peptide works?
No. Registration means a study was formally listed before or during the research. It says nothing about the result. A completed trial can find no benefit, and many registered studies are never published.
What is the difference between a registered trial and published evidence?
Registration records that a study exists. Publication reports what it found. This page counts registrations, which is the more complete picture of research activity, but it is not a measure of proven effectiveness.
Why do phases matter?
Phase 1 tests safety in a small group. Phase 2 looks for early signs of effect. Phase 3 tests effectiveness against a comparator in a large group, and is what regulators normally require. Phase 4 studies happen after approval. A compound with only Phase 1 trials has not been shown to work.
Source: ClinicalTrials.gov API v2, U.S. National Library of Medicine. Studies where Leuprolide is registered as an intervention. Last updated 2026-09-23.