Enclomiphene — Research Literature Summary
Class: Investigational SERM • Page type: research-literature reference • Updated 2026-04-23
Regulatory notice — research reference only
Enclomiphene citrate (Androxal) is an investigational selective estrogen receptor modulator (SERM). Its U.S. Phase III development program (by Repros Therapeutics) was halted; enclomiphene is NOT FDA-approved for any indication. This page summarizes the published clinical research literature only. Not for human use.
Published research summary
- Enclomiphene is the trans-isomer of clomiphene citrate. In Phase II and Phase III studies, oral enclomiphene raised serum testosterone in men with secondary hypogonadism while preserving sperm concentrations - in contrast to exogenous testosterone, which suppresses spermatogenesis.
- Repros Therapeutics' Phase III submission (NDA 204321) received a Complete Response Letter from the FDA in 2015 citing concerns about the bioequivalence endpoint. Development for that indication did not resume.
- Published clinical trials studied 12.5 mg/day and 25 mg/day oral doses for 3-6 months in men with secondary hypogonadism.
- Common adverse effects reported included headache, nausea, hot flashes, mood changes, and visual disturbances (a known SERM-class effect). Long-term cardiovascular and vision safety beyond trial durations is not established in peer-reviewed literature.
Why this page does not publish a consumer “cycle” schedule
Enclomiphene is not FDA-approved. 'Cycle,' 'PCT,' or 'testosterone enhancement' framing is consumer-market language, not a reflection of the peer-reviewed research record.
Peer-reviewed citations
- Wiehle RD, et al. J Androl 2014;35(2):244-251 (Phase II).
- Kaminetsky J, et al. BJU Int 2013;112(8):1188-1200.
- FDA Complete Response Letter for Androxal (enclomiphene), Repros Therapeutics press release, 2015.
Consulting a healthcare provider: This page is a reference for published research. If you are considering any health decision, consult a licensed healthcare provider. Path to Peptides does not provide medical advice.