● TIER 2 — Compoundable · emerging dataGRADE BReproductive hormones
Clomiphene / Enclomiphene
SERMs. Research verification: Yes (TGA pending). 2 human study record(s) in the FitClinicMD studies database.
GOALS · Hormone optimization / menopause / low T · Sexual function
FDA status
Clomiphene approved for female ovulation induction (off-label in men). Enclomiphene not approved (NDA not approved).
Compounding (503A/503B)
Clomiphene citrate: approved generics (USP monograph). Enclomiphene citrate: 503A Category 1 (under evaluation) — compounding permitted under FDA interim policy while evaluated; discussed at PCAC Jun 8 2022
DEA
Not controlled.
WADA (sport)
S4.2 Anti-estrogenic substances (incl. clomifene)
Mechanism
Hypothalamic ER antagonism ↑LH/FSH.
Human evidence · 2
Meta-analysis in hypogonadal men. Clomiphene citrate for men with hypogonadism: a systematic review and meta-analysis.
Enclomiphene phase 2 secondary hypogonadism. Oral enclomiphene citrate stimulates the endogenous production of testosterone and sperm counts in men with low testosterone: comparison with testosterone gel.
Reference only. This page summarizes publicly available regulatory and research information about Clomiphene / Enclomiphene. It is not a prescription, an endorsement, or an offer to dispense, and regulatory status can change. Clinicians should verify current status before prescribing or compounding.