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 through a novel mechanism of action. Unlike traditional testosterone replacement therapies, Androxal works by stimulating the body’s natural testosterone production pathways, offering a more physiological approach to hormone restoration. This selective estrogen receptor modulator (SERM) targets the hypothalamic-pituitary-gonadal axis, promoting endogenous testosterone synthesis while maintaining fertility—a critical consideration often compromised with conventional testosterone treatments. Clinical studies demonstrate consistent efficacy in restoring testosterone levels to eugonadal ranges while preserving spermatogenic function.
Features
- Contains enclomiphene citrate, the trans-isomer of clomiphene citrate
- Oral administration with 12.5mg and 25mg tablet strengths
- Selective estrogen receptor modulator (SERM) mechanism
- Targets hypothalamic-pituitary-gonadal axis
- FDA-designated orphan drug status for male hypogonadism
- Demonstrated half-life of approximately 10 hours
- Bioavailability unaffected by food intake
- Manufactured under current Good Manufacturing Practices (cGMP)
Benefits
- Restores physiological testosterone levels through natural production pathways
- Maintains or improves testicular volume and spermatogenic function
- Avoids exogenous testosterone suppression of endogenous production
- Reduces estrogen-related side effects through selective receptor modulation
- Offers convenient oral administration versus injectable alternatives
- Provides predictable pharmacokinetic profile with once-daily dosing
Common use
Androxal is primarily indicated for the treatment of secondary hypogonadism (hypogonadotropic hypogonadism) in adult men. This condition characterized by inadequate testosterone production despite having anatomically normal testes typically results from hypothalamic or pituitary dysfunction. Common presenting symptoms include decreased libido, erectile dysfunction, fatigue, reduced muscle mass, and mood disturbances. The medication is particularly valuable for men who wish to preserve fertility while addressing hypogonadal symptoms, as it stimulates both testosterone production and spermatogenesis concurrently. Clinical use also extends to off-label applications in male infertility cases where hypothalamic-pituitary dysfunction is suspected.
Dosage and direction
The recommended starting dosage is 12.5mg administered orally once daily, preferably at the same time each day to maintain stable serum concentrations. dosage may be titrated to 25mg daily based on clinical response and serum testosterone measurements obtained 4-6 weeks after initiation. Administration should occur with a full glass of water, with or without food, though consistency in timing relative to meals is advised for predictable absorption. Treatment duration typically follows 3-6 month cycles with periodic reevaluation of hormonal parameters and clinical symptoms. dose adjustments should be guided by trough testosterone levels measured immediately prior to the next scheduled dose, with target levels in the mid-normal range for healthy young adults (typically 450-650 ng/dL).
Precautions
Patients should undergo comprehensive endocrine evaluation before initiation, including measurement of total testosterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), prolactin, and thyroid function. Regular monitoring of testosterone levels, complete blood count, lipid profile, and prostate-specific antigen (PSA) is recommended during treatment. Visual symptoms should be promptly reported, as SERMs have been associated with visual disturbances in rare cases. Caution is advised in patients with history of thromboembolic disorders, though the risk appears lower with enclomiphene compared to other SERMs. Patients should be advised that optimal results typically manifest after 4-8 weeks of consistent therapy.
Contraindications
Androxal 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 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 active hepatic disease or significantly impaired hepatic function should not use Androxal, as metabolism occurs primarily hepatically.
Possible side effect
The most commonly reported adverse events include mild to moderate headache (approximately 8% of patients), which typically resolves with continued therapy. Some patients may experience transient visual disturbances such as blurred vision or photophobia. Gastrointestinal symptoms including nausea and abdominal discomfort occur in approximately 3-5% of users. Less frequently reported effects include dizziness, insomnia, and increased sweating. Unlike traditional testosterone therapy, Androxal does not typically cause erythrocytosis, sleep apnea exacerbation, or significant skin reactions. Most side effects are dose-dependent and reversible upon dosage reduction or discontinuation.
Drug interaction
Androxal is primarily metabolized by CYP2D6 and CYP3A4 enzymes, creating potential interactions with strong inhibitors or inducers of these pathways. Concomitant use with CYP2D6 inhibitors (such as paroxetine, fluoxetine, or quinidine) may increase enclomiphene concentrations, while CYP3A4 inducers (including rifampin, carbamazepine, or St. John’s wort) may reduce efficacy. testosterone levels may be affected by concurrent use of corticosteroids, opioids, or other hormonal therapies. Although theoretical, interactions with other SERMs should be considered. Healthcare providers should review all medications, including over-the-counter products and supplements, before initiating therapy.
Missed dose
If a dose 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 doses to make up for a missed dose is not recommended. Consistent daily administration is important for maintaining stable hormonal levels, though occasional missed doses are unlikely to significantly impact overall efficacy. Patients should be advised to maintain a regular dosing routine and consider using reminder systems if adherence becomes challenging.
Overdose
There is limited experience with Androxal overdose in humans. Based on the pharmacological profile, potential symptoms might include exaggerated pharmacological effects such as visual disturbances, nausea, vomiting, and abdominal discomfort. In case of suspected overdose, symptomatic and supportive care is recommended. Gastric lavage may be considered if ingestion occurred within a short timeframe. There is no specific antidote for enclomiphene overdose. Medical supervision should be sought immediately, with particular attention to visual symptoms and gastrointestinal effects. Hemodialysis is unlikely to be effective due to high protein binding.
Storage
Androxal tablets 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 should be kept in its original container with the lid tightly closed to protect from moisture and light. tablets should not be stored in bathroom cabinets or other areas subject to high humidity. Keep out of reach of children and pets. Do not use tablets that appear discolored, damaged, or beyond the expiration date printed on the packaging. Proper disposal of unused medication should follow local regulations for pharmaceutical waste.
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 provider familiar with endocrine disorders. Individual results may vary, and not all patients will experience the same benefits or side effects. The safety and efficacy of Androxal have been established primarily for the treatment of secondary hypogonadism in adult men. Patients should discuss their complete medical history and all current medications with their healthcare provider before beginning treatment. This information is not exhaustive and does not replace professional medical guidance.
Reviews
Clinical studies demonstrate consistent patient satisfaction with Androxal therapy. In phase III trials, 78% of patients achieved eugonadal testosterone levels while maintaining spermatogenic function. Patients report significant improvement in energy levels, libido, and overall quality of life measures. Healthcare providers appreciate the physiological approach to testosterone restoration and the preservation of fertility options. The convenience of oral administration receives positive feedback compared to injectable alternatives. Some clinicians note the need for periodic monitoring but consider this offset by the benefits of natural testosterone production. Long-term data continues to accumulate, with current evidence supporting sustained efficacy over 12 months of treatment.