Gonadorelin
Gonadorelin is a synthetic copy of gonadotropin-releasing hormone (GnRH), the brain hormone that tells the pituitary to release LH and FSH. Given in pulses, it switches the reproductive hormones on; given continuously, it switches them off. It is used as a test of pituitary function, in pump-based fertility treatment, and in cattle breeding.
Approval status
No human gonadorelin product is currently marketed in the US: the FDA lists Factrel and Lutrepulse as discontinued. In the UK, a gonadorelin injection is licensed as a diagnostic test of pituitary function. Veterinary gonadorelin injections such as Factrel (Zoetis) are FDA-approved for cattle and labeled not for human use.34527
What it’s used or studied for
- Approved use
Diagnostic test of how well the pituitary releases LH and FSH (injection licensed in the UK by the MHRA).5
- Approved use
Given in pulses by a small pump to induce ovulation in women with hypothalamic amenorrhea (Lutrepulse; approved by Health Canada, and by the FDA before its US discontinuation).648
- Human studies
Given in pulses by pump to men with congenital hypogonadotropic hypogonadism to start sperm production; it works in most men treated.910
- Animal & lab only
Veterinary only: FDA-approved for cattle, to treat ovarian follicular cysts and to time ovulation for fixed-time insemination. This is not a human use.2
- No studies
Promoted online for men on testosterone therapy to keep the testes active; no trials have tested this, and GnRH normally needs pulsed delivery to work.11
Each label shows how strong the evidence is: an approved use, human studies, animal or lab studies only, or a popular claim with no published studies. Being studied is not the same as being proven safe or effective.
Side effects
Common
- Pain
- Skin swelling or itching
- Hardening at the injection site
- Irritation, inflammation or infection at a pump needle site
- Headache
- Dizziness
- Nausea or abdominal discomfort
- Flushing
Serious or rare
- Severe allergic reactions (anaphylaxis) and bronchospasm
- Ovarian hyperstimulation (rare, with pump treatment)
- Multiple pregnancy (with pump treatment)
- Antibodies that stop it working (rare, with long-term use)
These come from the UK diagnostic label and the Canadian Lutrepulse label; most reported effects are mild and local. A meta-analysis of pump treatment in women found ovarian hyperstimulation was rare and mild.568
Cautions
- Continuous exposure to GnRH shuts down LH and FSH release instead of raising it.11
- Not for use in known or suspected pregnancy (UK diagnostic label).5
- The Lutrepulse label says it should not be used by women with ovarian cysts or hormone-dependent tumors, and pump treatment needs ultrasound monitoring because of the risk of multiple pregnancy.6
- Veterinary gonadorelin products are labeled for use in animals only, not for human use.2
Sources
- PubChem CID 638793: Gonadorelin
- FDA veterinary label: Factrel (gonadorelin hydrochloride) injection for cattle, NADA 139-237 (DailyMed)
- Drugs@FDA: NDA 018123, Factrel (gonadorelin hydrochloride), discontinued
- Drugs@FDA: NDA 019687, Lutrepulse (gonadorelin acetate), discontinued
- UK SmPC: Gonadorelin powder for solution for injection (Esteve Pharmaceuticals), revised 2022
- Health Canada product monograph: Lutrepulse (gonadorelin acetate for injection), revised 2016
- WADA 2026 Prohibited List
- Tranoulis A et al. Efficacy and safety of pulsatile GnRH therapy in hypothalamic amenorrhea: systematic review and meta-analysis (Fertil Steril, 2018)
- Dwyer AA et al. Current landscape of fertility induction in males with congenital hypogonadotropic hypogonadism (Ann N Y Acad Sci, 2024)
- Zhang L et al. The pulsatile gonadorelin pump induces earlier spermatogenesis than cyclical gonadotropin therapy in CHH men (Am J Mens Health, 2019)
- Cretu AM et al. Emerging peptide and neuroendocrine strategies for TRT-induced reproductive suppression (Front Reprod Health, 2026)
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