Is Gonadorelin (compounded) legal in the US?
No. The approved gonadorelin products are discontinued, and the version used here is made up by a pharmacy.
Gonadorelin was once sold as the FDA-approved products Factrel (a diagnostic) and Lutrepulse (a pump-delivered fertility treatment), both now discontinued in the United States, and no FDA-approved gonadorelin product is marketed as of 2026-10-26. The gonadorelin used alongside testosterone therapy is compounded and has no approved indication for that use. 3
No. The approved gonadorelin products were discontinued. Compounded versions are made without an approved use. Using it with testosterone therapy is off-label by definition, because there is no label. 3
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Citations
- 2021, World J Mens Health: pulsatile GnRH versus gonadotropin therapy in congenital hypogonadotropic hypogonadism, meta-analysis pubmed.ncbi.nlm.nih.gov
- Horm Res: pulsatile GnRH therapy in hypogonadotropic hypogonadism doi.org
- Drugs.com: gonadorelin (Factrel), discontinued in the US drugs.com
Reference information only, not medical advice. Drawn from the Gonadorelin (compounded) article, fact-checked against the cited sources. No dosing anywhere on this site.