Generic Enclomiphene

Introduction

Enclomiphene is a selective estrogen receptor modulator (SERM) that is the trans-isomer of the racemic mixture clomiphene citrate. It is supplied as a 50 mg oral tablet and is being investigated primarily for the treatment of male hypogonadism and certain forms of infertility. The compound is manufactured by several pharmaceutical companies that develop it for clinical research; it is not currently approved by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) for any indication. Clinical trials have explored its ability to raise endogenous testosterone while preserving spermatogenesis, distinguishing it from traditional testosterone replacement therapies. Enclomiphene is also studied off-label for female ovulatory disorders, although formal regulatory approval for these uses has not been granted.

What is Enclomiphene?

Enclomiphene is a synthetic, non-steroidal SERM that binds to estrogen receptors in the hypothalamus and pituitary gland. Chemically, it is the (E)-isomer of clomiphene citrate, whereas the (Z)-isomer is known as zuclomiphene. The drug is manufactured as a 50 mg oral tablet. Development began in the early s, with several biotech firms-most notably the company behind the investigational product “Androxal”-advancing it through Phase II and Phase III trials for endocrine disorders. Although not marketed under a brand name in major markets, the active compound is well-known to clinicians because of its close relationship to clomiphene, which is marketed under brand names such as Clomid® and Serophene® for female infertility.

How Enclomiphene Works

Enclomiphene exerts its effect by antagonizing estrogen feedback at the hypothalamic-pituitary axis. By blocking estrogen receptors in the hypothalamus, the drug reduces the inhibitory signal that normally limits the release of gonadotropin-releasing hormone (GnRH). Increased GnRH stimulates the anterior pituitary to secrete more luteinizing hormone (LH) and follicle-stimulating hormone (FSH).

• LH rise: In men, elevated LH prompts Leydig cells in the testes to produce more testosterone, boosting endogenous levels without the need for exogenous hormone administration.
• FSH rise: In both sexes, increased FSH supports spermatogenesis (in men) and follicular development (in women).

Pharmacokinetic data indicate that the oral tablet is absorbed rapidly, reaching peak plasma concentrations within 2-3 hours. The elimination half-life averages 8-12 hours, allowing once-daily dosing. Metabolism occurs primarily via hepatic cytochrome P450 enzymes (CYP3A4 and CYP2D6), and the drug is eliminated mainly in the urine as inactive metabolites.

Conditions Treated with Enclomiphene

Approved indications: None - Enclomiphene has not received formal approval from the FDA, EMA, or other major regulatory agencies for any therapeutic use. Consequently, it is classified as an investigational drug and is available only within clinical-trial settings or through regulated research programs.

Off-Label and Investigational Uses of Enclomiphene

Although not approved, several peer-reviewed studies have examined off-label applications:

1. Male secondary hypogonadism - Randomized controlled trials have shown that enclomiphene can raise serum testosterone by 150-250 ng/dL while preserving sperm counts, offering an alternative to injectable testosterone therapy.
2. Female anovulatory infertility - Small pilot studies suggest that enclomiphene may induce ovulation in women who are resistant to clomiphene citrate, possibly due to its more selective estrogen-receptor blockade.
3. Polycystic ovary syndrome (PCOS) - metabolic phenotype - Early-phase research indicates improvement in insulin sensitivity when enclomiphene is combined with lifestyle modification, though data remain limited.

All off-label uses remain unapproved by regulatory bodies. Patients should pursue such therapies only under the direct supervision of a qualified healthcare professional, with thorough discussion of the limited evidence base and potential risks.

Is Enclomiphene the Right Medication for You?

Enclomiphene may be considered for adult patients who meet the following criteria in an investigational context:

• Adult men (≥18 years) with documented secondary hypogonadism (low testosterone, normal/low gonadotropins) who wish to preserve fertility.
• Women with documented ovulatory dysfunction who have failed standard clomiphene therapy and are enrolled in a clinical trial evaluating enclomiphene-based protocols.

Contraindications include:

• Known hypersensitivity to enclomiphene or any component of the tablet.
• Active, untreated estrogen-dependent malignancies (e.g., breast cancer).
• Severe hepatic impairment (Child-Pugh class C).
• Pregnancy or breastfeeding, because the drug can interfere with fetal development.

Patients with a history of thromboembolic disease, uncontrolled hypertension, or visual disturbances should be evaluated carefully before initiation.

Risks, Side Effects, and Interactions

Common

• Headache - Usually mild and transient.
• Hot flashes - Related to estrogen-receptor modulation.
• Nausea or mild gastrointestinal upset - Often resolves after the first few doses.

Rare

• Visual disturbances - Including blurred vision or photopsia; requires prompt assessment.
• Mood changes - Such as irritability or mild depressive symptoms in a minority of users.

Serious

• Thromboembolic events - Deep-vein thrombosis or pulmonary embolism have been reported in patients with pre-existing risk factors.
• Hepatotoxicity - Elevated liver enzymes (ALT, AST) may occur; monitoring is advised in patients with liver disease.
• Severe hypersensitivity - Rash, angioedema, or anaphylaxis necessitating immediate medical attention.

Drug-Drug Interactions

• CYP3A4 inducers (e.g., rifampin, carbamazepine) - May lower enclomiphene plasma concentrations, reducing efficacy.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) - Can increase exposure, potentially heightening adverse-event risk.
• Anticoagulants (warfarin, DOACs) - Theoretical risk of altered clotting profile; monitor INR or clinical status when co-administered.

Drug-Food Interactions

• High-fat meals - May delay absorption but do not significantly affect overall exposure; taking the tablet with or without food is acceptable.
• Alcohol - Excessive intake can exacerbate hepatic strain and increase the risk of hot flashes.

Patients should inform their healthcare provider of all prescription, over-the-counter, and herbal products they are using.

Use: Dosing, Missed Dose, Overdose

Standard dosing: Clinical trials have employed a once-daily oral dose of 50 mg. Dosing adjustments are not routinely recommended outside a research protocol.

Missed dose: If a dose is forgotten, take it as soon as remembered on the same day. Do not take a double dose the following day; simply continue with the regular schedule.

Overdose: Signs may include severe nausea, vomiting, visual disturbances, or faintness. In the event of suspected overdose, seek immediate medical attention; supportive care (e.g., activated charcoal, observation) is the primary management strategy.

Practical precautions:

• Swallow tablets whole with a glass of water.
• Avoid taking the medication before operating heavy machinery until personal tolerance is known, as dizziness or visual changes can occur.
• Refrain from consuming large amounts of grapefruit juice, which can inhibit CYP3A4 metabolism.

FAQ

• What is the shelf life of enclomiphene tablets? Enclomiphene tablets are typically stable for 24 months when stored at temperatures between 15 °C - 30 °C (59 °F - 86 °F) in their original container, protected from moisture and direct sunlight.

• Can I travel internationally with enclomiphene? When traveling, keep the medication in its original labeled packaging and carry a copy of the prescription or clinical-trial documentation. Check the destination country’s import regulations, as some require a customs declaration for hormone-modulating agents.

• Does enclomiphene contain any allergens such as lactose or gluten? Formulations commonly include lactose monohydrate as a filler and microcrystalline cellulose; gluten is not listed as an ingredient. Patients with severe lactose intolerance should discuss alternatives with their provider.

• How does enclomiphene differ from clomiphene citrate? Clomiphene is a racemic mixture of both trans- (enclomiphene) and cis- (zuclomiphene) isomers. Enclomiphene provides a more selective estrogen-receptor antagonism, resulting in a clearer hormonal profile and fewer anti-estrogenic side effects in some studies.

• Is a blood test required before starting enclomiphene? Baseline evaluation usually includes serum testosterone, LH, FSH, liver function tests, and a complete metabolic panel to ensure eligibility and to monitor treatment response.

• Can enclomiphene be taken with hormonal contraceptives? Co-administration may diminish the contraceptive’s effectiveness due to altered estrogen metabolism; women using hormonal birth control should discuss alternative non-hormonal methods while on enclomiphene.

• What temperature should I store enclomiphene in a hot climate? In environments exceeding 30 °C (86 °F), store the tablets in a refrigerator (2 °C - 8 °C) or a climate-controlled cabinet to maintain potency.

• Do I need to avoid any over-the-counter supplements while on enclomiphene? Supplements containing high doses of phytoestrogens (e.g., soy isoflavones) might counteract the drug’s mechanism; it is advisable to limit such products unless approved by a clinician.

• Is urine drug testing affected by enclomiphene? Standard employment-type drug screens do not detect SERMs. However, specialized endocrine panels may identify elevated estradiol or testosterone levels, which could be flagged in certain occupational health assessments.

• Can I split the 50 mg tablet into smaller doses? Enclomiphene tablets are not scored, and splitting may result in inaccurate dosing. Use the tablet whole as prescribed; dose adjustments should be performed by a qualified professional.

Glossary

Selective Estrogen Receptor Modulator (SERM)

A class of compounds that bind to estrogen receptors and act as agonists in some tissues (e.g., bone) while antagonizing estrogen activity in others (e.g., hypothalamus).

Hypogonadism

A condition in which the gonads produce insufficient sex hormones; secondary hypogonadism involves impaired signaling from the brain rather than direct testicular or ovarian failure.

Pharmacokinetics

The study of how a drug is absorbed, distributed, metabolized, and excreted by the body.

CYP3A4

A major liver enzyme responsible for metabolizing many drugs; substances that induce or inhibit CYP3A4 can alter the plasma levels of medications processed by this pathway.

Buying Enclomiphene from Our Online Pharmacy

Patients who need enclomiphene but encounter limited availability through local pharmacies can obtain the medication from our online pharmacy. We source the 50 mg tablets directly from licensed, audited manufacturers, ensuring that each batch meets stringent quality-control standards comparable to those required by regulatory agencies.

• Cost-effective pricing - Our pricing model is based on wholesale acquisition costs, allowing us to pass savings on to you without compromising safety.
• Verified product integrity - Every shipment is accompanied by a certificate of analysis confirming potency, purity, and compliance with Good Manufacturing Practices (GMP).
• Discrete, reliable delivery - Orders are packaged in neutral, unbranded boxes and dispatched via secure carriers; typical delivery times are 7 days for express services and approximately 3 weeks for standard airmail.
• International access - Because enclomiphene is not widely stocked in many regions, our pharmacy broker service partners with overseas licensed pharmacies to bring the medication within reach of patients worldwide.
• Privacy-first approach - We handle all personal data in line with international privacy regulations (e.g., GDPR) and do not share information with third parties unrelated to order fulfilment.

By choosing our online pharmacy, you gain a trustworthy, affordable pathway to obtain enclomiphene when conventional channels are unavailable or financially prohibitive.

Disclaimer

The information presented about Enclomiphene is intended for general educational purposes only and does not substitute for professional medical advice. All therapeutic choices, including any off-label applications, must be made under the direct supervision of a qualified healthcare practitioner. Readers are assumed to be competent adults capable of making informed decisions regarding their health. Our online pharmacy provides a channel to obtain enclomiphene for individuals who may encounter restricted availability through traditional pharmacies or insurance-based dispensing, or who are seeking a cost-effective generic alternative. Prior to initiating, modifying, or discontinuing any medication, consult a qualified medical professional.