Enclomisign: Clinically Validated Testosterone Restoration Therapy
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Synonyms | |||
Enclomisign represents a significant advancement in the treatment of male hypogonadism, offering a selective estrogen receptor modulator (SERM) approach to testosterone restoration. Unlike traditional testosterone replacement therapy (TRT), which suppresses endogenous gonadotropin secretion and spermatogenesis, Enclomisign stimulates the hypothalamic-pituitary-gonadal (HPG) axis to promote natural testosterone production. This mechanism preserves—and often improves—fertility while effectively elevating serum testosterone levels into the eugonadal range. It is indicated for men with secondary hypogonadism who desire to maintain reproductive potential, providing a clinically validated alternative to exogenous androgen administration.
Features
- Active pharmaceutical ingredient: Enclomisign citrate
- Pharmacologic class: Selective estrogen receptor modulator (SERM)
- Mechanism of action: Competitive antagonism of estrogen receptors at the hypothalamus and pituitary
- Administration: Oral tablet
- Bioavailability: High oral absorption with first-pass metabolism
- Half-life: Approximately 10-14 hours
- Excretion: Primarily hepatic metabolism with renal elimination of metabolites
Benefits
- Stimulates endogenous testosterone production through physiologic HPG axis activation
- Maintains or improves semen parameters and fertility potential, a critical advantage over conventional TRT
- Avoids testicular atrophy and maintains intratesticular testosterone levels
- Provides predictable serum testosterone elevation with once-daily dosing
- Demonstrates favorable safety profile with extensive clinical validation
- Eliminates need for frequent injections or transdermal administration systems
Common use
Enclomisign is primarily prescribed for the treatment of secondary hypogonadism (hypogonadotropic hypogonadism) in adult men. This includes men with low serum testosterone levels accompanied by symptoms of hypogonadism—such as decreased libido, fatigue, reduced muscle mass, and mood disturbances—who have normal or low gonadotropin levels. It is particularly valuable for men who wish to preserve fertility or those who have experienced unsatisfactory results with traditional testosterone replacement therapy. The medication is also used off-label in certain cases of functional hypogonadism associated with obesity or metabolic syndrome, though this use requires careful clinical consideration.
Dosage and direction
The standard recommended dosage is 25 mg administered orally once daily, preferably taken at the same time each day to maintain stable serum concentrations. Tablets should be swallowed whole with water and may be taken with or without food, though consistency in administration relative to meals is recommended. Treatment initiation should be preceded by baseline assessment of serum testosterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol levels. Dosage adjustment may be necessary based on therapeutic response and serum hormone levels measured at 4-6 week intervals initially, with maintenance monitoring every 3-6 months thereafter. The maximum recommended daily dose is 50 mg. Treatment duration should be individualized based on therapeutic response and ongoing assessment of risk-benefit ratio.
Precautions
Patients should undergo comprehensive endocrine evaluation before initiation to confirm the diagnosis of secondary hypogonadism and exclude primary testicular failure. Regular monitoring of serum testosterone, LH, FSH, estradiol, and prolactin levels is essential during treatment. Hepatic function should be assessed at baseline and periodically during therapy, as with all SERMs. Patients with a history of thromboembolic disorders require careful risk-benefit assessment before initiation. Visual acuity and ocular examinations are recommended if visual disturbances occur. Caution is advised in patients with severe hepatic impairment or uncontrolled hypertension. Patients should be advised that response to therapy may vary and that full therapeutic effect may require several weeks of consistent dosing.
Contraindications
Enclomisign is contraindicated in patients with known hypersensitivity to enclomisign citrate or any component of the formulation. It must not be used in men with primary testicular failure (hypergonadotropic hypogonadism) as the mechanism of action requires functional Leydig cells. Additional contraindications include active deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis; severe hepatic impairment (Child-Pugh Class C); and untreated prolactin-secreting pituitary adenomas. Concomitant use with aromatase inhibitors or other SERMs is contraindicated due to potential pharmacologic antagonism.
Possible side effects
The most commonly reported adverse reactions (occurring in >5% of patients) include mild to moderate headache, nausea, and increased sweating. Less frequent side effects (1-5% incidence) comprise visual disturbances (including blurred vision), gastrointestinal discomfort, fatigue, and mood swings. Rare but potentially serious adverse effects (<1% incidence) include thromboembolic events, significant elevation of liver enzymes, and allergic reactions. Most side effects are dose-dependent and often diminish with continued therapy. Patients should be advised to report persistent or severe adverse effects, particularly visual changes, acute headache, or signs of thromboembolism.
Drug interaction
Enclomisign is primarily metabolized by CYP3A4 and may interact with strong inhibitors or inducers of this enzyme. Concomitant use with strong CYP3A4 inhibitors (ketoconazole, clarithromycin, ritonavir) may increase enclomisign exposure, potentially requiring dose reduction. Strong CYP3A4 inducers (rifampin, carbamazepine, St. John’s wort) may decrease efficacy. Warfarin requires careful monitoring as SERMs may potentiate anticoagulant effects. Concomitant use with other hormonal therapies, including testosterone preparations, may alter the endocrine response. Acid-reducing agents (proton pump inhibitors, H2 blockers) do not significantly affect absorption.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Doubling the dose to make up for a missed dose is not recommended. Consistent daily administration is important for maintaining stable hormone levels, so patients should be counseled on adherence strategies. Occasional missed doses are unlikely to significantly impact overall efficacy, but frequent missed doses may compromise therapeutic outcomes.
Overdose
There is limited experience with enclomisign overdose. Single doses up to 150 mg have been administered in clinical studies without severe adverse effects. Expected manifestations of significant overdose may include amplified pharmacologic effects: severe headache, pronounced hormonal fluctuations, gastrointestinal distress, and potential visual disturbances. Management should be supportive and symptomatic, with attention to hydration and monitoring of vital signs. Gastric lavage may be considered if ingestion occurred within 1-2 hours. There is no specific antidote; hemodialysis is unlikely to be effective due to high protein binding.
Storage
Store at controlled room temperature (20-25°C or 68-77°F) with excursions permitted between 15-30°C (59-86°F). Keep in the original container with the lid tightly closed to protect from moisture and light. Keep out of reach of children and pets. Do not use if the blister pack is damaged or tablets show signs of deterioration. Do not transfer to other containers as this may compromise stability. Properly discard any unused medication after the expiration date or when treatment is discontinued.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Enclomisign is available by prescription only and should be used under the supervision of a qualified healthcare provider. Treatment decisions must be based on individual patient characteristics and professional medical judgment. The prescribing physician should be familiar with the complete prescribing information and current clinical guidelines for testosterone deficiency management. Patients should disclose their complete medical history and all concomitant medications to their healthcare provider.
Reviews
Clinical studies demonstrate consistent efficacy in elevating serum testosterone levels while maintaining or improving semen parameters. In a 12-week randomized controlled trial, 78% of patients achieved eugonadal testosterone levels with enclomisign versus 42% with transdermal testosterone. Fertility parameters showed significant improvement in sperm concentration and motility compared to baseline. Long-term extension studies (up to 36 months) show sustained efficacy and favorable safety profile. Patient-reported outcomes indicate improvements in libido, energy levels, and mood. Healthcare providers note the advantage of oral administration and fertility preservation compared to traditional TRT. Real-world evidence continues to support the clinical trial findings with high patient satisfaction rates.