Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library
Cetrorelix (Cetrotide): what the evidence says
At a glance
What it is: an FDA-approved, injected decapeptide that blocks the GnRH receptor. R1 Approved to stop early LH surges in women having controlled ovarian stimulation. R2
What the evidence says: in a phase 3 RCT it prevented LH surges with shorter treatment than buserelin, with similar pregnancy rates. R3 A network meta-analysis compares antagonist protocols. R4 No human data for bodybuilding or "post-cycle" use.
Biggest risks: label contraindications include pregnancy, breastfeeding, severe kidney impairment and allergy to GnRH analogues. R2
Rating
| Human Human evidence | Strong for its IVF use R3, R4; no data for off-label uses |
| Animal Animal / lab evidence | Not reviewed here |
| Regulatory | FDA-approved, NDA 021197; generics approved · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page · not named on WADA's 2026 list R1, R5, R6, R7, R8 |
| Established human dose | Labeled fertility dosing only; see label R2 |
Evidence verdict: Preventing early ovulation in IVF: Strong (FDA-approved, phase 3 RCTs) · Bodybuilding or hormone 'reset': No human data
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: strong for the labeled fertility use; nothing supports other uses.
What is it?
Cetrorelix blocks the pituitary's GnRH receptor, so LH and FSH drop within hours. R2 Related pages: Degarelix, Leuprolide, Triptorelin, Gonadorelin, Kisspeptin-10.
Does it work?
- Human IVF phase 3 (n = 273): premature LH rise in only 1.6% on cetrorelix; similar fertilization and pregnancy rates to buserelin. R3
- Human Network meta-analysis 2023: compares antagonist timing protocols. R4
- Unknown Men, bodybuilding, "reset": no studies. Blocking GnRH lowers testosterone, the opposite of what these users want. R2
Is it safe?
- Human Label: contraindicated in pregnancy and lactation, severe renal impairment, and hypersensitivity to GnRH analogues or mannitol. R2
Gray-market vials: extra risks
A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.
Is it legal?
- US: prescription only (NDA 021197, with generic ANDAs). R1 not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. R6, R7, R8
- Sport: WADA S2.2.1 names GnRH agonist analogues; cetrorelix (an antagonist) is not named. R5
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| Phase 3 IVF 2000 | 273 women | SC | Per study | One stimulation cycle | LH surge 1.6%; similar pregnancy | PMID 10686191 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)
- R1 Drugs@FDA, Cetrotide (cetrorelix acetate), EMD Serono, approved Aug 11, 2000, application NDA021197 (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA021197
- R2 Cetrotide prescribing information, label published Sep 22, 2025 (DailyMed, checked Oct 26, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aca7768e-28a7-4027-b1d8-e66247665f79
- R3 Albano C, et al. Hum Reprod. 2000. PMID 10686191
- R4 Venetis CA, et al. Hum Reprod Update. 2023. PMID 36594696
- R5 WADA. The 2026 Prohibited List, S2.2.1 lists GnRH agonist analogues; GnRH antagonists such as cetrorelix are not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
- R6 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R7 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R8 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Cetrorelix (Cetrotide). Cetrorelix shuts down LH and FSH release; in men it lowers testosterone. Talk to a fertility specialist; it is not a performance or 'reset' drug. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).