Enclomiphene 10mg

Route: Oral capsule.

• Administer by mouth once daily, with or without food, at a consistent time each day.
• Swallow capsule whole with water; do not crush or chew.
• Consistent daily dosing maintains therapeutic LH/FSH stimulation and supports diurnal testosterone rhythm restoration.

Dosing is individualized by the prescribing clinician. Clinical reference ranges studied:

• Enclomiphene has been studied at 6.25 mg, 12.5 mg, and 25 mg once daily in phase II/III trials.
• 10 mg is a prescriber-directed starting or maintenance dose based on clinical judgment, serum testosterone response, and LH/FSH levels.
• Testosterone levels and LH/FSH should guide titration at follow-up visits (typically 4–8 weeks after initiation).
• The terminal half-life of enclomiphene is approximately 10 hours; LH/FSH elevation persists for several days after a single dose.

All dosing decisions are prescriber-directed.

• Enclomiphene: The trans-isomer of clomiphene acts as a pure estrogen receptor antagonist (unlike the cis-isomer zuclomiphene, which is estrogenic). It competitively blocks estrogen receptors in the hypothalamus and anterior pituitary, preventing negative feedback suppression of GnRH pulsatility. Increased GnRH pulse frequency stimulates the pituitary to release LH and FSH. Elevated LH stimulates Leydig cells in the testes to synthesize testosterone; elevated FSH supports Sertoli cell function and spermatogenesis. Unlike exogenous testosterone replacement therapy, enclomiphene preserves the HPG axis function and does not suppress sperm production.

Clinical Context: Enclomiphene is used off-label for secondary (hypogonadotropic) hypogonadism in men, characterized by low serum testosterone with low or inappropriately normal LH and FSH. It offers an alternative to exogenous testosterone replacement therapy (TRT) for men who wish to preserve fertility and endogenous testosterone production. It does not cause the azoospermia/oligospermia associated with TRT. Phase II/III clinical trials demonstrated normalization of serum testosterone (to 400–600 ng/dL) while maintaining sperm counts, with a favorable side effect profile.

Monitoring:

• Serum total testosterone (morning), LH, and FSH at baseline and 4–8 weeks after initiation or dose change.
• Serum estradiol: enclomiphene may mildly increase estradiol; monitor if gynecomastia or estrogenic symptoms occur.
• Semen analysis if fertility preservation is a clinical goal.
• Symptom assessment: energy, libido, mood, cognitive function.
• Complete blood count (polycythemia risk is lower than with TRT but should be assessed).

Contraindications:

• Hypersensitivity to enclomiphene or clomiphene.
• Women: not indicated for use in women (particularly not during pregnancy; related compound clomiphene is used for female ovulation induction under separate indication).
• Pre-existing ovarian cysts or liver disease (based on clomiphene class labeling).

Warnings & Precautions:

• Visual disturbances: blurred vision or other visual changes have been reported with clomiphene-class SERMs; discontinue and evaluate if vision changes occur.
• Estradiol elevation: monitor for gynecomastia or breast tenderness from aromatization of increased testosterone.
• Not for use in primary hypogonadism (testicular failure) — absent functional Leydig cells will not respond to HPG axis stimulation.

Drug Interactions:

• Other SERMs: potential additive effects on the HPG axis.
• Aromatase inhibitors: may be used adjunctively by prescribers to manage estradiol rise from increased testosterone; monitor estradiol.
• Hepatically metabolized medications: enclomiphene is metabolized in the liver; use caution with hepatotoxic agents.

Common Side Effects: Headache, abdominal discomfort, elevated estradiol, gynecomastia, mood changes, and visual disturbances (rare). Enclomiphene has a shorter half-life and fewer estrogenic side effects than racemic clomiphene.

Store at controlled room temperature (20–25°C / 68–77°F). Protect from moisture and light. Keep in tightly sealed container. Store out of reach of children. Use before the beyond-use date assigned by Genesis Compounding.

How is enclomiphene different from testosterone replacement therapy (TRT)?

TRT directly replaces testosterone using an exogenous source, which suppresses the HPG axis and typically causes azoospermia (absent sperm production). Enclomiphene stimulates the testes to produce their own testosterone by disinhibiting the HPG axis, preserving both natural testosterone production and sperm count — making it preferred when fertility is a concern.

How is enclomiphene different from clomiphene (Clomid®)?

Clomiphene is a racemic mixture of enclomiphene (trans-isomer) and zuclomiphene (cis-isomer). Zuclomiphene is estrogenic and has a very long half-life (up to 30 days), contributing to estrogenic side effects. Enclomiphene is the pure anti-estrogenic isomer with a shorter half-life (~10 hours), providing a more targeted effect with potentially fewer side effects.

How long does it take for testosterone to improve?

Serum LH and FSH typically rise within days of initiating enclomiphene. Testosterone levels normalize within 2–6 weeks in most men with functional Leydig cells. Repeat laboratory testing is typically performed 4–8 weeks after initiation.

Is this FDA-approved for male hypogonadism?

Enclomiphene (Androxal®) completed phase III trials but was not FDA-approved for male secondary hypogonadism. It is prescribed off-label and compounded by Genesis Compounding as a patient-specific 503A preparation.

Will I still produce sperm while taking enclomiphene?

Yes. Unlike TRT, enclomiphene does not suppress sperm production. Clinical studies have demonstrated maintained or improved semen parameters in men treated with enclomiphene, in contrast to significant decreases seen with testosterone replacement.