Androxal: Clinically Proven Testosterone Restoration Therapy
Androxal
| Product dosage: 50mg | |||
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| 60 | 1.50 $ | 128.70 $ 90.09 $ (30%) | 🛒 Add to cart |
| 90 | 1.29 $
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Androxal (enclomiphene citrate) represents a significant advancement in the treatment of male hypogonadism, specifically addressing secondary hypogonadism with a targeted physiological mechanism. Unlike traditional testosterone replacement therapies, Androxal stimulates the body’s natural testosterone production by acting as a selective estrogen receptor modulator (SERM) at the hypothalamic level. This approach not only elevates serum testosterone levels but also preserves or restores testicular function and spermatogenesis, offering a unique benefit for men concerned with fertility. Supported by robust clinical evidence, Androxal provides a effective and well-tolerated option for physicians managing hypogonadal patients who seek an alternative to exogenous testosterone.
Features
- Active ingredient: Enclomiphene citrate, the trans-isomer of clomiphene
- Pharmacological class: Selective estrogen receptor modulator (SERM)
- Available in 12.5 mg and 25 mg oral tablets
- Mechanism: Antagonizes estrogen receptors in the hypothalamus, increasing gonadotropin-releasing hormone (GnRH) pulse amplitude
- Stimulates pituitary release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
- Typically administered as a once-daily oral regimen
- Manufactured under current Good Manufacturing Practice (cGMP) standards
- Prescription-only medication requiring proper diagnostic confirmation
Benefits
- Restores physiologic testosterone levels through endogenous production
- Maintains or improves testicular volume and spermatogenesis, preserving fertility
- Avoids suppression of the hypothalamic-pituitary-gonadal (HPG) axis seen with exogenous testosterone
- Demonstrates significant improvements in testosterone levels, libido, and energy in clinical trials
- Oral administration offers convenience compared to injectable or transdermal alternatives
- Favorable safety profile with side effects generally mild and transient
Common use
Androxal is primarily indicated for the treatment of secondary hypogonadism (hypogonadotropic hypogonadism) in adult men. This condition is characterized by low testosterone levels resulting from insufficient stimulation of the testes by the pituitary gland, rather than primary testicular failure. Common presenting symptoms include decreased libido, erectile dysfunction, fatigue, reduced muscle mass, and mood changes. Patients typically considered for Androxal therapy include those with documented morning total testosterone levels below 300 ng/dL on at least two separate occasions, along with corresponding symptoms of hypogonadism. The medication is particularly suitable for men who wish to preserve fertility potential while addressing their hypogonadal symptoms, as well as those who prefer to avoid or have contraindications to traditional testosterone replacement therapy.
Dosage and direction
The recommended starting dosage of Androxal is 12.5 mg administered orally once daily, preferably in the morning. Based on clinical response and serum testosterone measurements obtained 2-4 weeks after initiation, the dose may be increased to 25 mg once daily if necessary to achieve target testosterone levels. Treatment should be taken with or without food, but consistency in administration relative to meals is recommended. Regular monitoring of testosterone levels, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) is essential during therapy to ensure appropriate dosing and response. The duration of treatment should be individualized based on therapeutic response and ongoing assessment of risk-benefit ratio. Androxal is not recommended for use beyond 12 months without thorough reevaluation of the continuing need for therapy and assessment of potential risks.
Precautions
Prior to initiating Androxal therapy, comprehensive evaluation should include measurement of serum testosterone, LH, FSH, prolactin, and assessment of pituitary function. Patients should be screened for conditions that may contraindicate testosterone therapy, including prostate cancer, breast cancer, and untreated prolactinomas. Regular monitoring of prostate-specific antigen (PSA), hematocrit, and lipid profiles is recommended during treatment. Androxal should be used with caution in patients with history of thromboembolic disorders, as SERMs have been associated with increased risk of venous thromboembolism. Visual disturbances have been reported with clomiphene citrate use; patients should be advised to report any visual symptoms promptly. Androxal may exacerbate symptoms of benign prostatic hyperplasia (BPH); patients should be monitored for worsening urinary symptoms. The medication should be prescribed only after confirmation of secondary hypogonadism and exclusion of primary testicular failure.
Contraindications
Androxal is contraindicated in patients with known hypersensitivity to enclomiphene citrate or any component of the formulation. It must not be used in men with primary testicular failure, as the mechanism of action requires functional testicular tissue. Additional contraindications include diagnosed or suspected prostate cancer, breast cancer, pituitary tumors (except properly treated prolactinomas), and untreated prolactinemia. The medication is contraindicated in patients with history of venous thromboembolism, including deep vein thrombosis and pulmonary embolism. Androxal should not be used in patients with liver disease severe enough to impair drug metabolism or those with uncontrolled heart failure. Concomitant use with other SERMs or testosterone products is contraindicated.
Possible side effect
The most commonly reported adverse reactions in clinical trials include headache (approximately 8% of patients), nausea (5%), dizziness (4%), and increased sweating (3%). Some patients may experience mild gastrointestinal disturbances such as abdominal discomfort or diarrhea. Visual disturbances including blurred vision, floaters, or photophobia have been reported in less than 2% of patients. Androxal may cause hot flashes in approximately 6% of users, though typically less severe than those associated with other SERMs. Rare cases of mood swings, insomnia, or fatigue have been reported. Laboratory abnormalities may include mild increases in liver enzymes, though clinically significant hepatotoxicity is uncommon. As with other SERMs, there is a potential risk of venous thromboembolic events, though the incidence with Androxal appears low based on available data.
Drug interaction
Androxal is primarily metabolized by CYP2D6 and to a lesser extent by CYP3A4, potentially interacting with inhibitors or inducers of these enzymes. Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine) may increase enclomiphene levels, while inducers may decrease efficacy. Concomitant use with other estrogenic or anti-estrogenic agents may alter the therapeutic effect. Androxal may affect the metabolism of warfarin, potentially requiring INR monitoring and dosage adjustment. The medication may interact with dopamine antagonists and drugs that affect pituitary function. Concurrent use with testosterone products or other treatments for hypogonadism is not recommended due to potential counteracting mechanisms. Androxal may affect thyroid function tests without altering thyroid status, potentially interfering with interpretation of results.
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. Patients should not take a double dose to make up for a missed dose. Consistency in daily administration is important for maintaining stable hormonal levels, but occasional missed doses are unlikely to significantly impact overall efficacy. Patients should be advised to maintain a regular dosing routine and consider using reminder tools if difficulty with adherence is anticipated. If multiple doses are missed, patients should contact their healthcare provider for guidance on resuming therapy.
Overdose
There is limited experience with Androxal overdose in humans. Based on the pharmacological profile, potential symptoms of overdose may include exaggerated pharmacological effects such as visual disturbances, nausea, vomiting, abdominal discomfort, and ovarian hyperstimulation syndrome-like symptoms (though less relevant in male patients). In case of suspected overdose, symptomatic and supportive care is recommended. Gastric lavage may be considered if ingestion occurred within a short time frame. There is no specific antidote for enclomiphene citrate overdose. Patients should be monitored for potential complications including thromboembolic events, and appropriate supportive measures implemented based on clinical presentation. Medical toxicology consultation is advised in cases of significant overdose.
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. Androxal should be kept out of reach of children and pets. Do not store in bathroom cabinets where humidity levels may fluctuate. Unused medication should be properly discarded after the expiration date or when no longer needed. Patients should be advised not to transfer tablets to other containers, as this may affect stability and lead to medication errors.
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. The content presented here is not exhaustive and may not include all relevant information about the product. Healthcare providers should reference the full prescribing information before initiating therapy. Patients should not make changes to their treatment regimen without consulting their physician. The efficacy and safety information is based on clinical trial data and may not reflect real-world experience in all patient populations.
Reviews
Clinical studies of Androxal have demonstrated significant improvements in testosterone levels, with mean increases from baseline ranging from 200-300 ng/dL in patients with secondary hypogonadism. In a 16-week randomized controlled trial, 78% of patients receiving Androxal 12.5 mg daily achieved average testosterone levels within the normal range, compared to 35% receiving placebo. Patient-reported outcomes showed significant improvements in sexual function, energy levels, and mood parameters. Fertility parameters including sperm concentration and motility were maintained or improved in most patients. Long-term extension studies have shown sustained efficacy over 12 months of treatment with maintained safety profile. Healthcare providers have reported satisfaction with the alternative mechanism of action that preserves testicular function while effectively addressing hypogonadal symptoms.