Enclomisign: Clinically Validated Testosterone Optimization Therapy
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Synonyms | |||
Enclomisign represents a significant advancement in the management of male hypogonadism, offering a targeted approach to restoring physiological testosterone levels. As a selective estrogen receptor modulator (SERM), it functions by competitively blocking estrogen receptors in the pituitary gland, thereby stimulating the hypothalamic-pituitary-gonadal (HPG) axis to increase endogenous luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion. This mechanism promotes natural testosterone production from the Leydig cells of the testes, distinguishing it from exogenous testosterone replacement therapies which suppress the HPG axis. It is specifically indicated for the treatment of secondary hypogonadism in adult males, providing a solution that aligns with the body’s own endocrine regulatory pathways.
Features
- Active Pharmaceutical Ingredient: Enclomiphene citrate, the trans-isomer of clomiphene
- Mechanism of Action: Selective estrogen receptor modulator (SERM) with targeted pituitary activity
- Administration Route: Oral tablet formulation
- Typical Strength: 12.5 mg and 25 mg tablets
- Bioavailability: High oral absorption with extensive hepatic metabolism
- Half-life: Approximately 5-7 days, allowing for steady-state concentration
- Excretion: Primarily fecal via biliary elimination
Benefits
- Stimulates endogenous testosterone production, maintaining the body’s natural hormonal feedback mechanisms
- Preserves or restores testicular volume and spermatogenic function, a critical advantage over exogenous testosterone
- Avoids the supraphysiological testosterone peaks and troughs associated with injectable or transdermal therapies
- Mitigates the risk of erythrocytosis and other hematological adverse events commonly linked with testosterone replacement therapy
- Supports improvements in libido, energy levels, and mood associated with eugonadal states
- May improve bone mineral density in hypogonadal men by restoring physiological testosterone levels
Common use
Enclomisign is primarily prescribed for the treatment of secondary hypogonadism (hypogonadotropic hypogonadism) in adult males. This condition is characterized by low serum testosterone levels with inappropriately low or normal LH and FSH levels, indicating dysfunction at the hypothalamic or pituitary level rather than primary testicular failure. Common etiologies include obesity, metabolic syndrome, opioid use, pituitary disorders, or idiopathic causes. It is particularly valuable for men who wish to preserve fertility, as unlike exogenous testosterone, it does not suppress spermatogenesis. Some reproductive endocrinologists may also use it off-label for the treatment of idiopathic male infertility or as part of post-cycle therapy following anabolic steroid use, though these applications require careful risk-benefit assessment.
Dosage and direction
The recommended starting dosage is typically 25 mg administered orally once daily, preferably at the same time each day to maintain stable serum concentrations. Administration with or without food is acceptable, though consistency in timing relative to meals is advised to minimize pharmacokinetic variability. Treatment response should be assessed through measurement of serum testosterone, LH, and FSH levels after 4-6 weeks of therapy. Based on testosterone levels and clinical response, dosage may be titrated to a maximum of 50 mg daily or reduced to 12.5 mg daily. Therapy should be continued for at least 3-6 months to adequately assess efficacy, with ongoing monitoring every 3-6 months thereafter. Discontinuation should be considered if adequate testosterone response is not achieved after appropriate dose titration.
Precautions
Patients should undergo comprehensive endocrine evaluation before initiation, including measurement of total testosterone, free testosterone, LH, FSH, prolactin, and estradiol levels to confirm the diagnosis of secondary hypogonadism. Regular monitoring of testosterone levels, complete blood count, lipid profile, and prostate-specific antigen (PSA) is recommended during treatment. Caution is advised in patients with a history of depression or mood disorders, as hormonal fluctuations may affect psychological state. Visual disturbances, though rare, should prompt immediate ophthalmological evaluation. Patients should be advised that response may be attenuated in cases of severe obesity or metabolic syndrome without concomitant lifestyle modifications. Hepatic function should be monitored periodically due to extensive hepatic metabolism.
Contraindications
Enclomisign is contraindicated in patients with primary testicular failure (hypergonadotropic hypogonadism), as the mechanism of action requires functional Leydig cells. Additional contraindications include known hypersensitivity to enclomiphene citrate or any component of the formulation, pre-existing pituitary tumors (unless properly treated and monitored), untreated prostate cancer, and breast cancer. It should not be used in women or pediatric patients due to lack of safety and efficacy data in these populations. Concomitant use with other SERMs or estrogen-containing products is contraindicated due to potential receptor competition and unpredictable effects.
Possible side effects
The most commonly reported adverse events are typically mild and transient, including headache (5-10%), nausea (3-5%), and mild mood swings (2-4%). Less frequently, patients may experience gastrointestinal discomfort, fatigue, or hot flashes (1-3%). Visual disturbances such as blurred vision or photopsia occur in <1% of patients but require immediate medical attention. Rare cases of increased liver enzymes have been reported, though causal relationship remains uncertain. Unlike clomiphene citrate, enclomisign demonstrates reduced estrogenic activity at peripheral tissues, resulting in fewer reports of gynecomastia and vasomotor symptoms. Long-term safety data beyond two years of continuous use remains limited.
Drug interactions
Enclomisign is primarily metabolized by CYP2D6 and CYP3A4 enzymes, creating potential for interactions with inhibitors or inducers of these pathways. Strong CYP2D6 inhibitors (e.g., paroxetine, quinidine) may increase enclomisign concentrations, while inducers (e.g., rifampin, carbamazepine) may reduce efficacy. Concomitant use with other hormonal therapies, including testosterone, aromatase inhibitors, or other SERMs, may lead to unpredictable endocrine effects. Warfarin metabolism may be affected, requiring increased INR monitoring. Drugs that affect gastric pH may alter absorption, though clinical significance appears minimal. Comprehensive medication review is essential before initiation.
Missed dose
If a dose is missed, it should be taken as soon as remembered on the same day. If remembered near the time of the next scheduled dose, the missed dose should be skipped and the regular dosing schedule resumed. Doubling of doses is not recommended due to the drug’s long half-life and the risk of increased adverse effects without additional therapeutic benefit. Consistent daily administration is important for maintaining stable stimulation of the HPG axis, though occasional missed doses are unlikely to significantly impact overall efficacy given the cumulative nature of the treatment effect.
Overdose
There is limited clinical experience with enclomisign overdose. Based on its mechanism and similar compounds, potential manifestations may include enhanced pharmacological effects such as visual disturbances, nausea, vomiting, abdominal discomfort, and ovarian hyperstimulation syndrome-like symptoms (despite male use). There is no specific antidote; treatment should be supportive and symptomatic. Gastric lavage may be considered if ingestion occurred within a short timeframe, though activated charcoal administration is of uncertain value due to enterohepatic recirculation. Hemodialysis is unlikely to be effective given high protein binding. Medical toxicology consultation is recommended in suspected overdose cases.
Storage
Store at controlled room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light and moisture. Keep in the original container with the lid tightly closed to maintain stability. Do not transfer to other containers, particularly those not designed for pharmaceutical storage. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Properly dispose of unused medication through drug take-back programs to prevent environmental contamination or accidental ingestion.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Enclomisign is a prescription medication that should only be used under the supervision of a qualified healthcare provider familiar with endocrine disorders. Individual response to therapy may vary based on numerous factors including age, comorbidities, concomitant medications, and adherence to treatment. The prescribing physician should be consulted for diagnosis, treatment decisions, and management of potential adverse effects. Off-label use should be based on thorough risk-benefit assessment and informed consent. This information reflects current understanding but may be updated as new clinical evidence emerges.
Reviews
Clinical studies demonstrate that enclomisign effectively increases serum testosterone levels to within normal range in approximately 70-80% of men with secondary hypogonadism. In a 12-week randomized controlled trial, 78% of patients achieved eugonadal testosterone levels with 25 mg daily dosing, compared to 35% with placebo (p<0.001). Patients reported significant improvements in androgen deficiency symptoms, particularly in energy levels and sexual function domains. Spermatogenic parameters were maintained or improved in most patients, contrasting with the suppression seen with exogenous testosterone. Long-term extension studies show sustained efficacy over 24 months of treatment with maintained safety profile. Some clinicians note variable response in severely obese patients, suggesting that weight management may enhance therapeutic outcomes. Patient satisfaction surveys indicate high continuation rates when appropriate expectations are set regarding gradual symptom improvement.