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Home/Compounds/Gonadorelin
OtherFDA approvedRx required

Gonadorelin

Also known as: GnRH · LHRH · Factrel
Brands: Factrel

Bioidentical gonadotropin-releasing hormone for fertility and testosterone support.

A
Grade A
Multiple human RCTs
Human studies26
PubMed citations29
Typical dose50 mcg – 200 mcg
Routesubcutaneous, intravenous
Regulatory (US)FDA approved · Rx
Last verified2 days ago
TL;DR · 30-second summary
  • Maintains testicular size and fertility during TRT
  • Diagnostic tool for pituitary function
  • Pulsatile delivery mimics natural physiology
  • Alternative to hCG for testosterone support

Mechanism of action

Synthetic GnRH identical to endogenous hormone. Pulsatile administration stimulates LH/FSH. Used to maintain testicular function during TRT or as fertility treatment.

Evidence summary

26
Human studies
29
PubMed citations
25
Clinical trials
A
Evidence grade

FDA approved for diagnostic use. Well-established for maintaining fertility during TRT. Pulsatile delivery required for therapeutic effect.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Dose range
50 mcg – 200 mcg

Typical: 100mcg subcutaneous 2x daily (mimics natural pulses). Some protocols use every other day.

Administration routes
subcutaneousintravenous

Side effects & safety

Reported side effects
HeadacheFlushingNauseaInjection site reactions
Contraindications
  • Hormone-sensitive cancers
  • Pregnancy

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved for diagnostic use. Off-label for fertility/TRT support.

Compounding
Permitted

Available through compounding pharmacies with valid prescription.

Regulatory data last verified 4/17/2026

Clinical trials

NCT06195709ECLECTIC: EstroTEP and Circulating Biomarkers to Determine the Optimal Second Line Therapy for ER-positive HER2-negative Metastatic Breast Cancer PatientsRecruiting · Phase 3 · Breast Carcinoma · n=300NCT05794906A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate CancerActive Not Recruiting · Phase 3 · Biochemically Recurrent Prostate Cancer · n=985NCT04076059China ARCHES: A Multicenter, Phase 3, Randomized, Double-blind, Placebo Controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)Active Not Recruiting · Phase 3 · Metastatic Hormone Sensitive Prostate Cancer · n=180NCT07287098preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast CancerNot Yet Recruiting · Phase 2 · Breast Neoplasms · n=600NCT05567198Efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by QuestionnairesRecruiting · Systemic Lupus Erythematosus (Sle) · n=100NCT05296798A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast CancerActive Not Recruiting · Phase 3 · Locally Advanced or Metastatic Breast Cancer · n=922NCT06179303A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast CancerRecruiting · Phase 2 · Anatomic Stage III Breast Cancer AJCC v8 · n=60NCT05827081A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)Recruiting · Phase 3 · Early Breast Cancer · n=1400NCT02858336CaREFREE Study (Calorie Restriction, Environment and Fitness: Reproductive Effects Evaluation Study)Completed · N/A · Hormones · n=38NCT02960022A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical StudyRecruiting · Phase 2 · Prostate Cancer · n=900NCT02160353Phase II Single-arm Study Evaluating Neo-adjuvant (Pre-radical Radiotherapy) Abiraterone Acetate (Plus Prednisolone) and Gonadotropin-Releasing Hormone (GnRH) Agonist in High Risk Localised Prostate CarcinomaCompleted · Phase 2 · High Risk Localised Prostate Carcinoma · n=45NCT04108208A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IV Study of Apalutamide in Chinese Participants With Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC)Active Not Recruiting · Phase 4 · Prostatic Neoplasms · n=75

Showing 12 of 25 indexed studies. View all on ClinicalTrials.gov →

Citations

PMID 40641861Wang JY, Zhang Y et al. · Oral Gonadotropin-Releasing Hormone Antagonists in the Treatment of Endometriosis: Advances in Research.Journal of clinical medicine research (2025)HumanPMID 40315284Paoletti AM, Neri M et al. · Pharmacokinetic considerations for gonadotropin-releasing hormone agonists and antagonists to treat endometriosis.Expert opinion on drug metabolism & toxicology (2025)HumanPMID 41465311Nayak P, Varani M et al. · Luteinizing Hormone-Releasing Hormone (LHRH)-Targeted Treatment in Ovarian Cancer.International journal of molecular sciences (2025)HumanPMID 38460874Melo DB, Coelho WM et al. · Effect of 200 μg of gonadorelin hydrochloride at the first GnRH of a CO-Synch program on ovulation rate and pregnancies per artificial insemination in Holstein heifers.Journal of dairy science (2024)PMID 36858006Torrini F, Scarano S et al. · Advances and perspectives in the analytical technology for small peptide hormones analysis: A glimpse to gonadorelin.Journal of pharmaceutical and biomedical analysis (2023)HumanPMID 31731249Hashem NM, Sallam SM · Reproductive performance of goats treated with free gonadorelin or nanoconjugated gonadorelin at estrus.Domestic animal endocrinology (2021)PMID 33670761Gründker C, Emons G · Role of Gonadotropin-Releasing Hormone (GnRH) in Ovarian Cancer.Cells (2021)HumanPMID 33623372Liu YF, Fu SQ et al. · Progress in Clinical Research on Gonadotropin-Releasing Hormone Receptor Antagonists for the Treatment of Prostate Cancer.Drug design, development and therapy (2021)HumanPMID 33238870Bettocchi C, Rinaldi M et al. · GnRH in the Treatment of Hypogonadotropic Hypogonadism.Current pharmaceutical design (2021)HumanPMID 33535622Emons G, Gründker C · The Role of Gonadotropin-Releasing Hormone (GnRH) in Endometrial Cancer.Cells (2021)HumanPMID 31379370Fabi A, Catania G · [LHRH analogs: current role in early and advanced breast cancer treatment of premenopausal patients.].Recenti progressi in medicina (2020)HumanPMID 28693207Hao D, Sun L et al. · 99mTc-LHRH in tumor receptor imaging.Oncology letters (2020)HumanPMID 29232843Tukun FL, Olberg DE et al. · Recent Development of Non-Peptide GnRH Antagonists.Molecules (Basel, Switzerland) (2018)HumanPMID 27021205Melis GB, Neri M et al. · Overview of elagolix for the treatment of endometriosis.Expert opinion on drug metabolism & toxicology (2017)HumanPMID 26353794Wei C, Crowne EC · Recent advances in the understanding and management of delayed puberty.Archives of disease in childhood (2016)HumanPMID 26951061Engel JB, Tinneberg HR et al. · Targeting of Peptide Cytotoxins to LHRH Receptors For Treatment of Cancer.Current drug targets (2016)HumanPMID 25890780Picard-Hagen N, Lhermie G et al. · Effect of gonadorelin, lecirelin, and buserelin on LH surge, ovulation, and progesterone in cattle.Theriogenology (2016)PMID 24431404Janakiram NB, Mohammed A et al. · Raloxifene and antiestrogenic gonadorelin inhibits intestinal tumorigenesis by modulating immune cells and decreasing stem-like cells.Cancer prevention research (Philadelphia, Pa.) (2015)HumanPMID 19626830Crawford ED, Hou AH · The role of LHRH antagonists in the treatment of prostate cancer.Oncology (Williston Park, N.Y.) (2009)HumanPMID 18201818Stangelberger A, Schally AV et al. · New treatment approaches for prostate cancer based on peptide analogues.European urology (2008)Human

Showing 20 of 29 papers. View all on PubMed →