Generic Androxal ( Enclomiphene )

Buy Generic Androxal (Enclomiphene ) without prescription in Canada

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Androxal (enclomiphene citrate) is a non-steroidal selective estrogen receptor modulator (SERM) primarily used in men to address secondary hypogonadism, a condition where low testosterone stems from insufficient signalling from the pituitary gland. It works by blocking the negative feedback of estrogen at the hypothalamus, which stimulates the body to release more luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This, in turn, naturally boosts the testicular production of testosterone and can support sperm production.

Usual adult dose: While not officially approved in Canada, the dosing range for enclomiphene described in clinical literature is typically 12.5 mg to 50 mg daily. Some protocols specifically reference taking 25 mg once daily, or 50 mg three to five days per week. Any dose must be individualized by a physician, and regular blood work is required to monitor hormone levels and tailor the appropriate regimen.

Dosage form: Oral capsules, available in strengths including 25 mg and 50 mg.

Onset of action: Increases in serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) can be observed within days, with studies demonstrating a significant rise in total testosterone within 14 days of daily use. Symptomatic relief from the effects of low testosterone may take several weeks.

Duration of action: The drug has a "legacy effect" where elevated testosterone, LH, and FSH levels can persist for at least one week after discontinuation. For sustained therapeutic effects, once-daily or periodic dosing is maintained.

Alcohol recommendation: Alcohol consumption should be limited during treatment with Androxal. Excessive alcohol can act as a testicular toxin, potentially impairing the natural testosterone production that enclomiphene aims to boost. Alcohol may also contribute to mood disturbances and interfere with the body's hormonal response.

Most common side effects: Common side effects may include headache, nausea, hot flashes, mood changes (such as irritability or aggression), and decreased libido. In some cases, men may experience breast tenderness or acne.

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General Information about Androxal (Enclomiphene)

• INN (International Nonproprietary Name): Enclomiphene (as enclomiphene citrate).
• Brand names available in Canada: There are no brand names officially marketed in Canada. The brand name "Androxal" is widely recognized and the active ingredient is available through select compounding pharmacies. Enclomiphene is not available as a standard commercial pharmaceutical product in the country.
• ATC code: G03GB02 (ovulation stimulants, synthetic).
• Dosage forms and strengths: Compounded oral capsules available in strengths of 12.5 mg, 25 mg, and 50 mg.
• Manufacturers in Canada: No specific Canadian manufacturer is authorized to commercially market the drug. The active pharmaceutical ingredient may be sourced by a handful of specialized compounding pharmacies to prepare individual patient prescriptions.
• Registration status in Canada: Not approved for sale in Canada. The medication has never received market authorization from Health Canada. For patients with serious medical conditions where conventional therapies have failed, enclomiphene can be accessed through a physician's request to the Health Canada Special Access Programme (SAP).
• OTC / Rx classification: Prescription only (Rx). It is available only through a valid prescription from a licensed Canadian practitioner, typically fulfilled by a compounding pharmacy or via special access.

Mechanism of Action and Pharmacology

Enclomiphene is the purified trans-isomer of clomiphene citrate, acting as a non-steroidal selective estrogen receptor modulator (SERM) with potent estrogen receptor antagonist properties. Unlike zuclomiphene (the cis-isomer found in regular clomiphene), enclomiphene acts as a pure antagonist at estrogen receptors in the hypothalamus and pituitary gland. In men with secondary hypogonadism, testosterone is low not because of testicular failure but due to inadequate stimulation by the pituitary hormones LH and FSH. Enclomiphene blocks the negative feedback loop where circulating estrogen (often produced by the aromatization of testosterone) would normally suppress gonadotropin-releasing hormone (GnRH) secretion. By blocking this feedback, GnRH secretion increases, which in turn stimulates the pituitary to release more LH and FSH. LH drives the Leydig cells in the testes to produce more testosterone, while FSH supports sperm production (spermatogenesis). This dual action helps reverse the two core defects of secondary hypogonadism—low serum testosterone and low or inappropriately normal gonadotropin levels—while preserving, and potentially improving, semen parameters. The elimination half-life of enclomiphene is considerably shorter than that of zuclomiphene (approximately 10 hours versus approximately 30 days), meaning the drug is rapidly cleared from the body. This short half-life allows for more flexible dosing and less accumulation in the system. The serum half-life of free enclomiphene has been estimated at about 10.5 hours.

Indications

• The primary indication is the treatment of secondary hypogonadism in men, specifically to boost endogenous testosterone production while preserving fertility (spermatogenesis).
• It is used as an off-label treatment alternative to standard testosterone replacement therapy (TRT) in men who wish to maintain or improve their sperm count.
• It has been studied for its potential to improve symptoms of hypogonadism, such as low libido, erectile dysfunction, fatigue, and mood disturbances.
• Enclomiphene is not approved for use in women, though some early clinical interest in this isomer for ovulation induction exists. The primary therapeutic focus is on male reproductive health.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: Enclomiphene is not intended for use in women. It is contraindicated in pregnant women. If a woman becomes pregnant while using the medication, it should be discontinued immediately, and the physician should be informed.
• Breastfeeding: It is not known whether enclomiphene is excreted in human milk. Because it is not indicated for female use, its administration to nursing mothers is contraindicated.
• Paediatrics (< 18 years): The safety and efficacy of enclomiphene have not been established in children or adolescents. Use is not recommended.
• Elderly: While age is not a direct contraindication, the risk of polycythemia (elevated hematocrit) and potential cardiovascular events may increase with age. Doses should be minimized and monitoring intensified.
• Hepatic impairment: Enclomiphene is metabolized by the liver. It should not be used in men with active liver disease or chronic liver dysfunction with persistently abnormal liver function tests.
• Renal impairment: Caution is advised, and dosage adjustments may be necessary. Clinical data are limited in this population.
• Hormone-sensitive cancers: Enclomiphene is contraindicated in patients with active prostate or breast cancer, as the rise in testosterone and estrogen levels could theoretically stimulate hormone-dependent tumor growth.
• Thromboembolic disorders: Men with a history of blood clots (deep vein thrombosis, pulmonary embolism) or clotting disorders (e.g., Factor V Leiden) should not use enclomiphene due to the reported risk of thromboembolism associated with SERMs.
• Cardiovascular disease: It is contraindicated in patients with recent myocardial infarction, unstable angina, or high-risk arrhythmias. The increase in hematocrit from elevated testosterone can increase blood viscosity.
• Psychiatric disorders: Use with caution in men with a history of significant mood or psychiatric disorders, as enclomiphene can cause mood swings, irritability, and aggression, and is contraindicated in those with unstable conditions requiring recent hospitalization.

Driving and alcohol

Enclomiphene is not known to directly impair the mental alertness required for driving or operating machinery. However, it is sometimes associated with mood swings, visual disturbances (e.g., blurred vision), or fatigue, which could indirectly affect safety. Patients should determine how they react to the medication before driving. Alcohol should be limited, as heavy drinking can cause liver stress and is a direct testicular toxin, potentially negating the therapeutic goal of boosting natural testosterone.

Dosage Instructions

• Standard dosage: Enclomiphene is not approved by the FDA or Health Canada for any standard dosing indication. Clinically, the dose is tailored to the individual. Common regimens include 25 mg to 50 mg taken orally once daily. Some protocols involve taking 25 mg three to five days per week to balance efficacy and tolerability.
• Administration: It is typically taken by mouth with or without food. For consistency, it is best to take it at the same time each day. Capsules should be swallowed whole and not crushed or chewed.
• Missed dose: If a dose is missed, it should be taken as soon as possible on the same day. If it is close to the time of the next scheduled dose, the missed dose should be skipped. Do not double the dose to catch up.
• Discontinuation: Do not abruptly stop the medication without consulting the prescribing physician, as testosterone and gonadotropin levels will gradually fall back to hypogonadal baselines, and symptoms of low testosterone may return.

Side Effects and Contraindications

• Common side effects: Headache, mild nausea, hot flashes, mood changes (irritability, aggression, or depression), decreased libido, fatigue, breast tenderness or enlargement (gynecomastia), and acne. These effects are often dose-dependent and may diminish over time.
• Serious side effects: Vision changes, including blurred vision, floaters, or partial vision loss, are a rare but serious signal to discontinue therapy. Blood clots in the legs or lungs (deep vein thrombosis or pulmonary embolism) can occur. Liver toxicity, presenting as jaundice, dark urine, or upper abdominal pain, has been reported. Priapism, a painful and prolonged erection, is also a rare event requiring immediate medical attention.
• Contraindications: Known hypersensitivity to enclomiphene or any component of the capsule. Current or past use of anabolic steroids. Active heart problems (unstable angina, recent heart attack, severe congestive heart failure). Active liver disease or chronic liver dysfunction. A history of serious vision problems such as Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION). Active hormone-sensitive cancer (prostate or breast). Polycythemia (high hematocrit >54%). A history of blood clotting disorders.

Drug Interactions

• Nitrates and other vasodilators: Because enclomiphene boosts endogenous testosterone and is sometimes co-prescribed with PDE5 inhibitors such as tadalafil (Cialis), the combination with nitrates (e.g., nitroglycerin) or guanylate cyclase stimulators is contraindicated due to the risk of a profound and dangerous drop in blood pressure.
• Anabolic steroids: The use of illicit anabolic steroids or testosterone supplements will suppress the hypothalamic-pituitary-gonadal (HPG) axis, directly opposing the action of enclomiphene. They must be discontinued for at least 6 months prior to starting enclomiphene.
• Warfarin and other anticoagulants: Estrogen receptor modulators can theoretically interact with coumarin anticoagulants. Enclomiphene may potentiate the effects of warfarin, and the INR should be monitored very closely if co-administered.
• Oral contraceptives: These contain estrogens and progestins that will compete with enclomiphene at the estrogen receptor, potentially interfering with its therapeutic intent. Concomitant use is not recommended.
• Antiestrogens (e.g., tamoxifen) and aromatase inhibitors (e.g., anastrozole): Additive effects on estrogen blockade may occur, which could potentially over-suppress estrogen and lead to estrogen-deficiency symptoms such as joint pain and bone loss. Their use together requires careful hormonal balance monitoring.

Practical Advice

• Administration: Take the capsule by mouth at the same time each day. It can be taken with or without food. Strict adherence to the prescribed dosing schedule is crucial for maintaining stable hormone levels.
• Monitoring: Therapy must be overseen by a physician experienced in men’s hormonal health. Regular blood tests (typically every 4 to 12 weeks after starting or changing the dose) are required to measure total testosterone, estradiol, LH, FSH, complete blood count (especially hematocrit), and liver function. The aim is to restore testosterone to the physiological range and maintain a hematocrit below 54%. PSA levels should also be monitored in men over 40.
• Storage: Store at room temperature (15‑30 °C) in a tightly closed, light-resistant container, away from moisture and heat. Keep out of the reach and sight of children.
• Lifestyle: The medication works best in conjunction with lifestyle practices that support hormonal health: weight training and cardiovascular exercise, a nutrient-rich diet, adequate sleep (7‑9 hours per night), and stress management techniques. These habits can help maximize the body’s natural testosterone response.
• Medical Alert Card: Patients should carry a card or note in their wallet stating they are on enclomiphene, particularly if they are also taking PDE5 inhibitors, to alert emergency medical personnel.

Alternative Medications

• Clomiphene citrate (Clomid): A mixture of enclomiphene and zuclomiphene, it is a widely used, off-label treatment for secondary hypogonadism in men wanting to preserve fertility. It is less "clean" pharmacologically, as zuclomiphene accumulates and can cause more estrogenic side effects, such as mood swings and breast tenderness.
• Testosterone Replacement Therapy (TRT): Gels (AndroGel), injections (Depo-Testosterone), and patches are first-line treatments for hypogonadism. They are highly effective but suppress the pituitary, shutting down FSH and LH, which leads to testicular atrophy and often causes infertility.
• Human chorionic gonadotropin (hCG): An injectable hormone that mimics LH, directly stimulating the testes to produce testosterone and maintain fertility. It is often used in combination with TRT or as monotherapy but is more costly and requires frequent injections.
• Aromatase inhibitors (Anastrozole): These block the conversion of testosterone to estrogen, which also reduces negative feedback on the pituitary. They are sometimes used off-label for hypogonadism but can lead to excessive estrogen suppression, bone density loss, and joint pain.
• PDE5 inhibitors (Tadalafil, Sildenafil): While they do not raise testosterone, they directly address erectile dysfunction, a key symptom of hypogonadism. They are sometimes combined with enclomiphene to treat concurrent erectile dysfunction and testosterone deficiency.

Clinical Efficacy

Enclomiphene has been evaluated in men with secondary hypogonadism, demonstrating a consistent ability to reverse the hallmarks of the condition: low serum testosterone and low or inappropriately normal LH levels. In a randomized Phase II clinical trial comparing enclomiphene citrate to topical testosterone gel, enclomiphene treatment resulted in increased morning serum total testosterone and estradiol levels comparable to those achieved with the gel, while crucially preserving sperm production. A systematic review and meta-analysis of randomized controlled trials found that clomiphene and enclomiphene citrate are effective in increasing testosterone levels in men with functional hypogonadism, with the additional benefit of preserving spermatogenesis, making the drug class a fertility-preserving alternative to standard testosterone replacement therapy. In a direct comparative study against the mixed isomer clomiphene citrate, enclomiphene was associated with statistically significantly fewer adverse events, including a lower rate of decreased libido, reduced energy, and mood changes. This is attributed to enclomiphene's pure estrogen receptor antagonist activity, which avoids the agonist effects of zuclomiphene. Even though enclomiphene did not receive full FDA approval for reasons including concerns about early-stage clinical trial design and potential thromboembolic risk, the British Society for Sexual Medicine (BSSM) recognizes it as a promising oral therapy for men with secondary hypogonadism who wish to preserve fertility or are intolerant to injectable and transdermal formulations.

Important:

Androxal (enclomiphene) is a prescription medication that has not been approved for marketing by Health Canada. It should only be used under the close supervision of a qualified healthcare professional, typically a specialist in men's health or endocrinology. It may only be legally obtained in Canada through a valid prescription from a physician, which may be fulfilled by a licensed compounding pharmacy or via the Health Canada Special Access Programme (SAP). Patients must undergo comprehensive baseline testing, including measurement of hematocrit, liver function, and prostate-specific antigen (PSA), and must be monitored at regular intervals. The drug is strictly contraindicated in patients with active hormone-sensitive cancers, significant cardiovascular disease, or a history of thromboembolic events. If you develop symptoms such as sudden vision loss, swelling or pain in a leg, chest pain, or shortness of breath, seek immediate emergency medical attention. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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