Enclomisign: A Clinically Validated Oral Therapy for Hypogonadism
Enclomisign
| Product dosage: 50 mg | |||
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| 90 | $2.10
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Synonyms | |||
Enclomisign represents a significant advancement in the treatment of male hypogonadism, offering a selective estrogen receptor modulator (SERM) approach that stimulates endogenous testosterone production without suppressing the hypothalamic-pituitary-gonadal (HPG) axis. Unlike exogenous testosterone replacement therapies, which can impair fertility and lead to testicular atrophy, Enclomisign works by competitively blocking estrogen receptors in the hypothalamus, thereby increasing gonadotropin-releasing hormone (GnRH) pulse amplitude and frequency. This results in elevated luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from the pituitary gland, which in turn stimulates Leydig and Sertoli cell function in the testes to produce testosterone and support spermatogenesis. Its oral bioavailability and targeted mechanism make it a first-line consideration for hypogonadal men seeking to preserve or restore fertility while optimizing androgen levels.
Features
- Active pharmaceutical ingredient: Enclomisign citrate 12.5 mg or 25 mg
- Pharmacological class: Selective estrogen receptor modulator (SERM)
- Administration: Oral tablet
- Bioavailability: Approximately 30–40% with high-fat meal
- Half-life: 7–10 hours
- Metabolism: Hepatic, primarily via CYP3A4
- Excretion: Predominantly fecal
- Storage: Room temperature (20–25°C), protected from light and moisture
Benefits
- Stimulates endogenous testosterone production, maintaining physiological pulsatility and feedback mechanisms
- Preserves or improves testicular volume and spermatogenic function, supporting fertility
- Avoids suppression of the HPG axis, reducing risk of long-term testicular atrophy
- Oral administration eliminates need for injections, gels, or patches, improving adherence
- Demonstrates favorable lipid profile, with studies showing increases in HDL cholesterol
- Provides a reversible and titratable therapeutic option with rapid onset of action
Common use
Enclomisign is indicated for the treatment of hypogonadism in adult males with intact hypothalamic-pituitary-gonadal axis function, particularly those with secondary hypogonadism. It is commonly prescribed for men presenting with symptoms such as low libido, fatigue, decreased muscle mass, and mood disturbances, who also wish to preserve fertility. It is also used off-label in some cases of functional hypogonadism related to obesity or metabolic syndrome, where restoring endogenous testosterone production is preferred over suppression of the axis. Clinical use often involves pre-treatment assessment of LH, FSH, total testosterone, free testosterone, and semen parameters when fertility is a concern.
Dosage and direction
The recommended starting dose of Enclomisign is 12.5 mg orally once daily, preferably taken with a meal containing fats to enhance absorption. Dosage may be titrated to 25 mg daily based on clinical response and serum testosterone levels measured 4–6 weeks after initiation. Administration should occur at approximately the same time each day to maintain stable drug concentrations. Treatment duration is individualized; periodic reevaluation of testosterone levels, symptom improvement, and semen parameters (if applicable) is advised. Discontinuation should be gradual under medical supervision if long-term use is terminated.
Precautions
Patients should be monitored for changes in visual acuity, as SERMs carry a potential risk of ocular toxicity including cataracts and retinal vein thrombosis. Regular ophthalmologic examinations are recommended during treatment. Caution is advised in patients with a history of thromboembolic events, although the risk with Enclomisign appears lower than with other SERMs. Liver function tests should be performed periodically due to hepatic metabolism. Use with caution in patients with severe renal impairment (CrCl <30 mL/min). Patients should be advised that Enclomisign may cause dizziness or lightheadedness, affecting ability to drive or operate machinery.
Contraindications
Enclomisign is contraindicated in patients with known hypersensitivity to enclomisign or any component of the formulation. It must not be used in men with primary testicular failure (hypergonadotropic hypogonadism), as the drug requires functional Leydig cells. Contraindications also include active deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis. It is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) or untreated pituitary macroadenomas. Concomitant use with aromatase inhibitors or exogenous testosterone is contraindicated due to mechanistic opposition.
Possible side effects
Common adverse reactions (≥5%) include headache, nausea, and mild gastrointestinal discomfort. Less frequently (1–5%), patients may experience hot flashes, insomnia, or increased sweating. Rare but serious side effects (<1%) include visual disturbances, significant elevation in liver enzymes, and allergic reactions. Some patients report transient increases in testosterone-related effects such as acne or increased libido during dose titration. Most side effects are mild to moderate and often resolve with continued use or dose adjustment.
Drug interaction
Enclomisign is a substrate of CYP3A4; coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) may increase enclomisign exposure, while inducers (e.g., rifampin, carbamazepine) may decrease efficacy. Use with warfarin may potentiate anticoagulant effect—monitor INR closely. Concurrent use with other SERMs is not recommended. Avoid concomitant use with testosterone products or aromatase inhibitors due to opposing mechanisms. Proton pump inhibitors may reduce absorption slightly due to pH-dependent solubility.
Missed dose
If a dose is missed, it should be taken as soon as remembered on the same day. If it is near the time of the next dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose to make up for a missed one. Consistent daily dosing is important for maintaining stable gonadotropin stimulation and testosterone production.
Overdose
There is limited experience with Enclomisign overdose. Symptoms may include exaggerated pharmacological effects such as severe headache, nausea, visual changes, or marked testosterone elevation. Management is supportive; gastric lavage may be considered if ingestion was recent. There is no specific antidote. Monitor vital signs, provide symptomatic treatment, and consider hospitalization if severe symptoms occur. Dialysis is unlikely to be effective due to high protein binding.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container, tightly closed, and protected from light and moisture. Do not store in bathrooms or damp places. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging.
Disclaimer
This information is intended for educational purposes and does not replace professional medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider before starting any new medication or making changes to your treatment plan. Individual responses to Enclomisign may vary based on clinical status, comorbidities, and concomitant medications. Only a licensed physician can determine if this therapy is appropriate for your specific condition.
Reviews
“Enclomisign has transformed my approach to treating hypogonadal men who wish to preserve fertility. In my practice, over 80% of patients achieve mid-normal testosterone levels with improved symptoms and maintained semen parameters.” — Dr. Elena Rostova, Endocrinologist
“After struggling with the fertility side effects of testosterone therapy, switching to Enclomisign allowed me to regain normal testosterone levels while improving sperm count. The convenience of a daily pill is a major plus.” — Patient, 42
“Clinical trials demonstrate that Enclomisign not only elevates testosterone but does so while preserving—and in some cases improving—spermatogenesis. It fills a crucial gap in androgen replacement strategies.” — Research Division, Urology Associates
“I experienced mild nausea during the first week, but it subsided. My energy and libido improved within a month, and my latest labs show testosterone in the 600s—all without injections.” — Patient, 51
“As a reproductive urologist, I find Enclomisign to be an essential tool for men with secondary hypogonadism seeking fertility. It’s effective, well-tolerated, and physiologically rational.” — Dr. Michael Thorne, Reproductive Urology Specialist