Enclomiphene 12.5 mg - 28 capsules

Route: Oral capsule.

• Take one capsule by mouth once daily, with or without food.
• Administer at a consistent time each day (typically in the morning) to align with the natural diurnal testosterone rhythm.
• Swallow capsule whole; do not open or crush.
• Complete the full 28-day supply as directed by the prescriber; laboratory follow-up is typically scheduled near the end of the supply period.

Dosing is prescriber-directed. 12.5 mg once daily is within the range studied in phase II/III clinical trials of enclomiphene for male secondary hypogonadism. Key dosing considerations:

• Clinical trials demonstrated testosterone normalization with both 12.5 mg and 25 mg once daily.
• The 12.5 mg dose is often used as a starting or conservative maintenance dose, with titration to 25 mg based on serum testosterone and clinical response.
• LH, FSH, and testosterone levels are reassessed at 4–8 weeks to guide dose adjustment.
• Enclomiphene's half-life of approximately 10 hours supports once-daily dosing; LH/FSH elevation persists several days after a missed dose.

• Enclomiphene (12.5mg): Competitively antagonizes estrogen receptors (ERα, ERβ) at the hypothalamus and pituitary, blocking estrogen-mediated negative feedback on GnRH pulsatility. Increased GnRH pulse frequency drives pituitary LH and FSH secretion. Elevated LH stimulates Leydig cell testosterone synthesis; elevated FSH supports Sertoli cell function and sperm production. Because enclomiphene acts upstream (stimulating endogenous production rather than replacing testosterone exogenously), HPG axis integrity and testicular function are preserved.

Clinical Context: 12.5 mg enclomiphene once daily is prescribed for men with secondary (hypogonadotropic) hypogonadism — low testosterone with inappropriately low or normal LH/FSH — particularly when fertility preservation is important. Phase III studies demonstrated normalization of serum testosterone while preserving sperm density, in contrast to testosterone replacement therapy which suppresses spermatogenesis. This dosage level is appropriate for initial treatment in men with milder testosterone deficiency or as a maintenance dose after response confirmation at higher doses.

Monitoring:

• Serum total testosterone (morning), LH, FSH, and estradiol at 4–8 weeks.
• Semen analysis if fertility preservation is a goal.
• Symptom reassessment (energy, libido, mood, cognitive function).
• Estradiol monitoring for potential gynecomastia.
• Visual assessment: discontinue if visual disturbances develop.

Contraindications:

• Hypersensitivity to enclomiphene or clomiphene class drugs.
• Primary (testicular) hypogonadism — absent Leydig cells will not respond to HPG stimulation.
• Women — enclomiphene at this dose is not indicated for female use.
• Pre-existing hepatic disease.

Warnings & Precautions:

• Visual disturbances: discontinue and evaluate if any visual changes develop.
• Estradiol elevation from aromatization of increased testosterone — monitor; co-prescribe anastrozole if clinically indicated.
• Not a substitute for TRT in primary hypogonadism or in patients requiring rapid testosterone normalization.

Drug Interactions:

• Other SERMs: potential additive HPG axis effects.
• Aromatase inhibitors: often co-prescribed to manage estradiol rise.
• Hepatotoxic agents: use with caution given hepatic metabolism.

Common Side Effects: Headache, elevated estradiol, gynecomastia, abdominal discomfort, mood changes, visual disturbances (rare). Lower incidence of estrogenic side effects compared to racemic clomiphene due to absence of the zuclomiphene isomer.

Store at controlled room temperature (20–25°C / 68–77°F). Protect from moisture and light. Keep in original sealed container. Store out of reach of children. Use before the beyond-use date assigned by Genesis Compounding. The 28-capsule supply should be used within the dispensed period; contact Genesis if additional supply is needed before the beyond-use date.

Why does this come as a 28-capsule supply?

A 28-capsule supply corresponds to a one-month course at once-daily dosing. This is calibrated to align with a follow-up clinical visit and laboratory reassessment (testosterone, LH, FSH) at approximately 4 weeks, allowing the prescriber to evaluate response and make any dose adjustments before dispensing the next supply.

What if I miss a dose?

Take the missed dose as soon as remembered unless it is close to the next scheduled dose — do not double up. Enclomiphene's HPG axis stimulatory effect persists for several days after a single dose, so a single missed dose is unlikely to cause a significant hormone dip. Contact the prescriber if multiple consecutive doses are missed.

Will this increase my sperm count?

Enclomiphene stimulates FSH, which supports Sertoli cell function and spermatogenesis. Unlike testosterone replacement therapy, it does not suppress sperm production and may help maintain or improve sperm parameters. A semen analysis at 3–6 months of treatment is appropriate if fertility is a clinical goal.

How is this different from a higher 25mg dose?

12.5 mg and 25 mg both increase testosterone and gonadotropins in clinical trials. The 12.5 mg dose produces a somewhat lower testosterone increase and may have a slightly more conservative side effect profile. The prescriber selects the dose based on baseline testosterone deficit, symptom severity, and laboratory response.

Is this product FDA-approved?

Enclomiphene (Androxal®) was studied extensively in phase III trials but was not FDA-approved for male secondary hypogonadism. This is a compounded, patient-specific 503A preparation prepared by Genesis Compounding under prescriber direction.