Research information only, not medical advice. Gonadorelin is a synthetic decapeptide identical to natural gonadotropin-releasing hormone (GnRH), which stimulates the pituitary to release LH and FSH. Its branded US products — Factrel (diagnostic use) and Lutrepulse (pulsatile pump therapy) — were FDA-approved but were voluntarily withdrawn from the market for commercial reasons, not safety or efficacy. As of 2026 no FDA-approved gonadorelin product is commercially available in the US; it is used off-label, mainly via compounding pharmacies, including as a testicular-function adjunct during testosterone therapy — an off-label use with no large randomised controlled trials.
Gonadorelin at a glance
Gonadorelin's historical evidence base comes from the diagnostic and pulsatile-therapy trials that supported its former FDA approvals (Factrel for pituitary-gonadotroph function testing, Lutrepulse for pulsatile treatment of hypothalamic amenorrhoea). Those products were withdrawn from the US market in commercial decisions, not for safety reasons. Its current off-label use — preserving testicular function during testosterone replacement therapy — has not been evaluated in large randomised controlled trials; the evidence for that specific use is limited.
See how we grade evidence for the methodology behind this page.
Evidence profile
174 studies- Human trial 13 · 7%
- Review 48 · 28%
- Animal 80 · 46%
- In-vitro 16 · 9%
- Unknown 17 · 10%
The longer the green, the stronger the human evidence. For most research peptides the bar is dominated by animal and in-vitro work, which is a signal to read every claim carefully.
Regulatory status
Clinical trials
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Hormone Therapy in Treating Patients With Advanced Prostate Cancer
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Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
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Bicalutamide Compared With Observation Followed by Bicalutamide Plus Either Goserelin or Orchiectomy in Treating Patients With Prostate Cancer
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Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
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Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
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A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer
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Androgen Suppression Combined With Elective Nodal and Dose Escalated Radiation Therapy
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Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer
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Hormone Therapy With or Without Squalamine Lactate in Treating Patients Who Are Undergoing a Radical Prostatectomy for Locally Advanced Prostate Cancer
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FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
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Casodex/Zoladex Biomarkers in Localised Prostate Cancer
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Prostate Adenocarcinoma TransCutaneous Hormones
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Bevacizumab, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
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Investigation of Early Hormonotherapy Efficacy of Prostate Cancer
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Pulsatile GnRH in Anovulatory Infertility
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The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study
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Pazopanib Hydrochloride After Leuprolide Acetate or Goserelin Acetate in Treating Patients With Relapsed Prostate Cancer
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Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg)
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A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Zoladex 3.6mg Combined With CEF Chemotherapy as Neo-Adjuvant Therapy in Hormone Responsive, Premenopausal, Operable Breast Cancer
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GnRH Agonist and Antagonists in an Oocyte Donation Program
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Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer
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Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
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Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy
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Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism
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Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02
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Human Menopausal Gonadotropin (HMG) vs Recombinant Follicle Stimulating Hormone (rFSH) in Gonadotropin Releasing Hormone (GnRH) Antagonist Cycles
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A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height
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Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
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Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment
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Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
- NCT01311037 UNKNOWN
The Combination of GnRh Analogue and Aromatase Inhibitor in Receptor Positive Premenopausal Women With Advanced Breast Cancer
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EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
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Ipilimumab + Androgen Depravation Therapy in Prostate Cancer
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Efficacy and Safety of Leuprolide Acetate 22.5 mg Depot in Treatment of Prostate Cancer
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Efficacy and Safety of TAK-385 in the Treatment of Endometriosis
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Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA
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Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)
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A Neoadjuvant Study of Androgen Ablation Combined With Cyclophosphamide and GVAX Vaccine for Localized Prostate Cancer
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Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain
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Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer
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Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer
- NCT01942369 COMPLETED
A Study to Describe the Efficacy of Diphereline Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months
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Efficacy Study Evaluating Chemotherapy in Prostate Cancer
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TRial on the Endocrine Activity of Neoadjuvant Degarelix
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Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome
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Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
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Everolimus trIal for Advanced prememopausaL Breast Cancer Patients
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Study of GnRH-A [Leuprorelin(Lorelin Depot] Plus Leterozole +/- Everolimus for Premenopausal Women With Metastatic Breast Cancer
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Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas
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Biosimilar Versus Urinary Gonadotropins
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Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity
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Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer
- NCT02630641 COMPLETED
Perception of Cohesion Within a Relationship (Dyadic Adjustment) on the Quality of Life of Patients With Prostate Cancer With Gonadotropin-releasing Hormone.
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Effectiveness and Safety Study of Fixed Versus Flexible of Gonadotropin-releasing Hormone Antagonist Protocol
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A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids
- NCT02673632 UNKNOWN
The Influence of AMH on Ovarian Responsiveness to Ovulation Induction With GnRH in Women With PCOS
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Efficacy and Safety of Medication Used to Stimulate Ovulation
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A Study of Definitive Therapy to Treat Prostate Cancer
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Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
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Co-treatment With GnRH Analogs on the Ovarian Reserve in Young Women Treated With Alkylating Agents for Cancer
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Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer
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PalbocIclib in PreMenopausal Women With ER Positive/HER-2 Negative MetAstatic Breast Cancer
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Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
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Effects of SNP of GnRH Receptor Genes in IVF Patients
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Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer
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Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer
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A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients
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Systemic Hormones and Muscle Protein Synthesis
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A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer
- NCT03230994 UNKNOWN
Cooperative Adenomyosis Network
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Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis
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Menopause Effects on Vascular Function
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Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients
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Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma
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Neoadjuvant Goserelin for Triple Negative Breast Cancer
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Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant
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Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
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HDR Brachytherapy, EBRT and STAD for the Treatment of Prostate Cancer
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Density Lowering Effect of "OFS Add on to TMX"(DELFINO Trial)
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Comparison of the Live Birth Rate Between the PPOS and the GnRH Antagonist Protocol in Patients Undergoing IVF
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Accuracy of Ultrasound Markers Versus Biochemical Markers in Prediction of Ovarian Response in Obese Women Undergoing IVF/ICSI Treatment
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Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2)
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Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-1)
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Follicular Fluid Sialic Acid Levels in IVF Cycles
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A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery
- NCT03867357 COMPLETED
Intramuscular Mechanisms of Androgen Deprivation-related Sarcopenia
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Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer
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PersonaLized neoAdjuvant Strategy ER Positive and HER2 Negative Breast Cancer TO Increase BCS Rate
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FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer
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REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer
- NCT04188275 UNKNOWN
CIRCULATING MICRO-RNA (miRNA) AND AR-V7 MUTATIONAL STATUS IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC): PRIMERA+ STUDY (PROSTATE CANCER INNOVATING MARKERS OF EXPECTED RESPONSE TO AGONIST LHRH+ ANDROGEN RECEPTOR INHIBITION
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Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
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GnRH Therapy on Cognition in Down Syndrome
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Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
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Role of Suppression of Endometriosis With Progestins Before IVF-ET
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Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients
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A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer
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Effect of Education on Treatment Decision Making for Patients With Prostate Cancer on Chronic Hormone Treatments
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Neoadjuvant Therapy of Abiraterone Plus ADT for Intraductal Carcinoma of the Prostate
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Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle
- NCT04854707 COMPLETED
An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
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Intramuscular Injection of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles
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Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer
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Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)-China Extension
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Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics (NoMEN Study)
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A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.
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Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)
- NCT05087706 UNKNOWN
Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer（MAPS）
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A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation
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Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support
- NCT05341128 COMPLETED
A Study of Medical Records From Children With Central Precocious Puberty (CPP) in China
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Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate
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Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate
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A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After HSCT
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Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers
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Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)
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Contributions to Hypertension With Androgen Deprivation Therapy
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Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy
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Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)
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Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone（GnRH）Antagonist Protocol in Women Undergoing IVF
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A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
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Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
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Effect of a GnRH Analog on Hepatic Steatosis
- NCT06812559 COMPLETED
Progesterone Primed Ovarian Stimulation Versus GnRH Antagonist Protocols in Women With Polycystic Ovarian Syndrome
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Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer
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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
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COMPASS - COpenhagen MenoPAuSe Study
- NCT07519213 COMPLETED
Guangdong Endometriosis Retrospective Clinical Cohort
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RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Indexed research
Sorted by evidence level, strongest first.
- Human trial 2026Restoring ovulation in functional hypothalamic amenorrhea: impact of polycystic ovarian morphology on hormonal response to pulsatile GnRH
This observational study found that women with functional hypothalamic amenorrhea and polycystic ovarian morphology had higher baseline AMH levels and no significant AMH increase after pulsatile GnRH therapy, unlike those without PCOM.
- Human trial 2026Protocol flexibility in PCOS: a combination of controlled ovarian stimulation and endometrial preparation strategies shows no impact on live birth outcomes after frozen embryo transfer-a retrospective cohort study
This retrospective cohort study found that in PCOS patients, live birth rates after frozen embryo transfer did not significantly differ among various combinations of controlled ovarian stimulation protocols and endometrial preparation methods.
- Human trial 2026Diagnostic performance of a simplified GnRH stimulation test in central precocious puberty: a multicentre study
This multicentre study evaluated whether shortening the GnRH stimulation test by measuring luteinizing hormone at 60 minutes maintains diagnostic accuracy for central precocious puberty in children.
- Human trial 2025Diagnostic accuracy of the triptorelin stimulation test for central precocious puberty in girls
This retrospective study evaluated the diagnostic accuracy of subcutaneous triptorelin compared to intravenous gonadorelin for diagnosing central precocious puberty in girls, finding comparable accuracy with an optimal LH peak cut-off of 7.14 IU/L at 180 minutes.
- Human trial 2025Is the triptorelin stimulation test comparable to the gonadorelin stimulation test in diagnosing central precocious puberty in boys?
This letter compares the diagnostic accuracy of triptorelin stimulation test versus gonadorelin stimulation test for central precocious puberty in boys.
- Human trial 2026Diagnostic Usefulness of Subcutaneous Triptorelin Stimulation Testing in the Evaluation of Central Precocious Puberty in Girls
This retrospective study of 662 girls with suspected central precocious puberty found that subcutaneous triptorelin stimulation testing yields similar luteinizing hormone response patterns to gonadorelin and may be a practical diagnostic alternative.
- Human trial 2026Extended Endocrine Therapy and Survival for Breast Cancer Subtypes in Premenopausal Patients
This multicenter cohort study found that extended endocrine therapy was associated with lower risks of invasive and distant recurrence across all surrogate breast cancer subtypes in premenopausal patients with node-positive, hormone receptor-positive early breast cancer, with the greatest risk reduction observed in luminal A-like disease.
- Human trial 2026Dynamic Profiles of Serum Kisspeptin and DLK1 During GnRH Stimulation in Central Precocious Puberty and Premature Thelarche
This cross-sectional study found that dynamic changes in serum kisspeptin and DLK1 during GnRH stimulation differ between girls with central precocious puberty and premature thelarche, but diagnostic utility is limited due to considerable overlap.
- Human trial 2026Supplementary Material for: Dynamic Profiles of Serum Kisspeptin and DLK1 During GnRH Stimulation in Central Precocious Puberty and Premature Thelarche
This cross-sectional study examined dynamic serum kisspeptin and DLK1 levels during GnRH stimulation in girls with central precocious puberty and premature thelarche, finding distinct percentage changes at 60 minutes that may help differentiate the conditions but with uncertain diagnostic utility.
- Human trial 2026Supplementary Material for: Dynamic Profiles of Serum Kisspeptin and DLK1 During GnRH Stimulation in Central Precocious Puberty and Premature Thelarche
This study found that the dynamic responses of serum kisspeptin and DLK1 to GnRH stimulation differ between girls with central precocious puberty and premature thelarche, though their diagnostic utility remains uncertain.
+ 164 more studies indexed for Gonadorelin.
Frequently asked questions
- Is Gonadorelin approved for human use?
- Gonadorelin is a synthetic decapeptide identical to natural gonadotropin-releasing hormone (GnRH), which stimulates the pituitary to release LH and FSH. Its branded US products — Factrel (diagnostic use) and Lutrepulse (pulsatile pump therapy) — were FDA-approved but were voluntarily withdrawn from the market for commercial reasons, not safety or efficacy. As of 2026 no FDA-approved gonadorelin product is commercially available in the US; it is used off-label, mainly via compounding pharmacies, including as a testicular-function adjunct during testosterone therapy — an off-label use with no large randomised controlled trials.
- What does the research on Gonadorelin show?
- Gonadorelin's historical evidence base comes from the diagnostic and pulsatile-therapy trials that supported its former FDA approvals (Factrel for pituitary-gonadotroph function testing, Lutrepulse for pulsatile treatment of hypothalamic amenorrhoea). Those products were withdrawn from the US market in commercial decisions, not for safety reasons. Its current off-label use — preserving testicular function during testosterone replacement therapy — has not been evaluated in large randomised controlled trials; the evidence for that specific use is limited.