Androxal: Clinically Validated Testosterone Restoration Therapy
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Androxal (enclomiphene citrate) represents a significant advancement in the treatment of male hypogonadism, specifically addressing secondary hypogonadism with a targeted, non-testosterone mechanism. This selective estrogen receptor modulator (SERM) works at the hypothalamic-pituitary level to stimulate the body’s own endogenous testosterone production, restoring physiological hormonal balance. It offers a novel approach for men seeking to correct low testosterone levels while preserving fertility and testicular function, distinguishing it from traditional testosterone replacement therapy (TRT). Supported by robust clinical data, Androxal provides a evidence-based option for physicians managing functional hypogonadism in appropriate patient populations.
Features
- Active pharmaceutical ingredient: Enclomiphene citrate (the trans-isomer of clomiphene)
- Mechanism: Selective estrogen receptor modulator (SERM) with activity at hypothalamic and pituitary levels
- Administration: Oral tablet formulation
- Bioavailability: Well-absorbed with predictable pharmacokinetics
- Half-life: Approximately 24 hours, allowing for once-daily dosing
- Metabolism: Hepatic, primarily via CYP2D6 and CYP3A4 pathways
- Excretion: Primarily fecal (approximately 85%), with renal clearance accounting for remainder
Benefits
- Restores physiological testosterone production through natural hypothalamic-pituitary-gonadal axis stimulation
- Maintains or improves testicular volume and spermatogenesis, preserving fertility potential
- Avoids exogenous testosterone suppression of intratesticular testosterone production
- Provides predictable dose-response relationship with established therapeutic monitoring parameters
- Offers convenient oral administration compared to injectable or transdermal testosterone formulations
- Demonstrates favorable safety profile in clinical trials with appropriate patient selection
Common use
Androxal is indicated for the treatment of secondary hypogonadism (hypogonadotropic hypogonadism) in adult men with demonstrated low testosterone levels and associated symptoms. Typical candidates include men presenting with fatigue, decreased libido, erectile dysfunction, mood changes, and reduced muscle mass who have confirmed hypogonadism with low serum testosterone and inappropriately low or normal gonadotropin levels. The medication is particularly suitable for men who wish to preserve fertility or who have concerns about the potential side effects associated with traditional testosterone replacement therapy. Clinical use requires comprehensive endocrine evaluation to confirm the diagnosis of secondary hypogonadism and exclude primary testicular failure or other contraindications.
Dosage and direction
The recommended starting dosage of Androxal is 12.5 mg administered orally once daily, preferably at the same time each day. Administration may occur with or without food, though consistency in timing relative to meals is recommended to maintain stable pharmacokinetics. Dose titration may be performed based on clinical response and serum testosterone measurements obtained 2-4 weeks after initiation. The maximum recommended dosage is 25 mg daily. Treatment duration should be individualized based on therapeutic goals and ongoing assessment of benefits versus risks. Regular monitoring of testosterone levels, symptom response, and potential adverse effects is essential throughout therapy. Androxal should not be crushed or chewed and should be taken with a full glass of water.
Precautions
Prior to initiating Androxal therapy, comprehensive endocrine evaluation must 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. Patients should be counseled regarding potential visual disturbances and instructed to discontinue medication immediately and seek ophthalmological evaluation if visual symptoms develop. Caution is advised in patients with history of depression, as mood changes may occur. Hepatic function should be assessed periodically, particularly in patients with pre-existing liver disease or those taking concomitant medications with hepatic metabolism. Androxal may increase testosterone levels to supraphysiological ranges in some patients, requiring dose adjustment.
Contraindications
Androxal is contraindicated in patients with primary testicular failure (hypergonadotropic hypogonadism). Additional contraindications include known hypersensitivity to enclomiphene citrate or any component of the formulation, pituitary tumors (unless properly treated and stable), and untreated prostate cancer. The medication is not indicated for use in women and is absolutely contraindicated during pregnancy due to potential teratogenic effects. Patients with uncontrolled thyroid or adrenal dysfunction should not receive Androxal until these conditions are properly managed. History of venous thromboembolism or hypercoagulable states represents a relative contraindication requiring careful risk-benefit assessment.
Possible side effect
Clinical trial data demonstrate that Androxal is generally well-tolerated, with most adverse effects being mild to moderate in severity. Commonly reported side effects include headache (approximately 8% of patients), nausea (5%), dizziness (4%), and increased sweating (3%). Some patients may experience injection site reactions if administered improperly. Less frequently reported effects include visual disturbances (blurred vision, photophobia), mood changes, fatigue, and gastrointestinal discomfort. Elevations in hematocrit may occur but are typically less pronounced than with exogenous testosterone therapy. Serious adverse events are rare but may include thromboembolic events, severe allergic reactions, or significant psychological effects in susceptible individuals.
Drug interaction
Androxal is metabolized primarily by CYP2D6 and CYP3A4 enzymes, creating potential for interactions with inhibitors or inducers of these pathways. Strong CYP2D6 inhibitors (such as paroxetine, fluoxetine, quinidine) may increase enclomiphene levels, while inducers (such as rifampin) may decrease efficacy. Concomitant use with other hormonal therapies, including testosterone, anabolic steroids, or aromatase inhibitors, may alter the hormonal effects of Androxal. Anticoagulant medications may require dose adjustment due to potential effects on clotting parameters. Drugs that affect pituitary function (dopamine agonists, somatostatin analogs) may interfere with the mechanism of action. Comprehensive medication review is essential before initiation and during therapy.
Missed dose
If a dose of Androxal is missed, patients should take it 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 of doses to make up for a missed dose is not recommended. Consistent daily administration is important for maintaining stable testosterone levels, so patients should be counseled on adherence strategies. If multiple doses are missed, consultation with the prescribing physician is recommended before resuming therapy, as assessment of testosterone levels may be warranted.
Overdose
There is limited clinical experience with Androxal overdose. Based on the pharmacological profile, potential manifestations may include exaggerated pharmacological effects such as significantly elevated testosterone levels, visual disturbances, gastrointestinal distress, and neurological symptoms. Management should be supportive and symptomatic, with close monitoring of vital signs and appropriate symptomatic treatment. There is no specific antidote for enclomiphene overdose. Hemodialysis is unlikely to be effective due to high protein binding and extensive tissue distribution. In cases of suspected overdose, immediate medical attention should be sought, and the poison control center consulted for latest management recommendations.
Storage
Androxal should be stored 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). The medication must be kept in the original container with the lid tightly closed to protect from moisture and light. Storage in bathrooms or other areas with high humidity should be avoided. Androxal should be kept out of reach of children and pets. Unused medication should be properly disposed of according to local regulations and not flushed down toilets or drains. The expiration date printed on the packaging should be strictly observed.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Androxal is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Individual results may vary, and not all patients will experience the described benefits. The safety and efficacy of Androxal have been established through clinical trials but continue to be monitored in post-marketing surveillance. Patients should discuss their medical history, current medications, and treatment goals with their physician before initiating therapy. This information does not replace comprehensive product labeling or professional medical judgment.
Reviews
Clinical studies demonstrate that Androxal effectively increases testosterone levels in men with secondary hypogonadism. In phase III trials, approximately 80% of patients achieved testosterone levels within the normal range with 12.5 mg daily dosing. Patient-reported outcomes show significant improvement in symptoms of hypogonadism, including energy levels, sexual function, and mood. Endocrinologists note the particular value of Androxal for men wishing to preserve fertility while treating hypogonadism. Some practitioners report that patient satisfaction is high due to the oral formulation and maintenance of testicular function. Ongoing research continues to explore optimal patient selection and long-term outcomes with Androxal therapy.