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Off-label (male) / approved (female) — clinician-directed. For female ovulation induction the approved regimen is 50 mg once daily for 5 days starting early in the cycle, titrated up to 100-150 mg if needed. For off-label male hypogonadism, observational studies used roughly 25-50 mg daily or every other day (25 mg/day is the most common starting dose), titrated to testosterone and LH/FSH response. There is no FDA-approved male dose.
Any time
Clomiphene citrate tablets (racemic — approved for women; off-label in men)
Investigational / off-label — no FDA-approved dose exists. Trials studied oral enclomiphene citrate at 6.25-25 mg once daily (12.5 mg and 25 mg were the Phase-3 doses). Compounded enclomiphene is used off-label under a clinician at similar doses, but quality and content are not regulated.
Any time
Oral enclomiphene citrate (compounded; investigational — never marketed as an approved drug)
Per cycle (5-10 day course)
Weeks to a few months
Within 3-6 months
Weeks to a few months
Within 3-6 months
N/A
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