Basic Androxal Information

• International Nonproprietary Name (INN): Enclomifene
• Brand Names Available in Australia: Androxal® (not commercially available), EnCyzix (tentative)
• ATC Code: Not assigned
• Forms & Dosages: Oral tablets (12.5 mg & 25 mg)
• Manufacturers in Australia: Repros Therapeutics Inc.
• Registration Status in Australia: Not approved
• OTC / Rx Classification: Prescription-only in investigational settings

Critical Warnings & Restrictions

Absolute Contraindications:

• Hypersensitivity to enclomifene/clomifene compounds
• Hormone-dependent tumours
• Pregnancy (teratogenic risk)

Relative Contraindications:

• Severe hepatic or renal impairment
• Uncontrolled pituitary or ovarian disorders
• History of thrombosis or embolism

Patient Safety Focus:

Understanding the critical warnings surrounding the use of Androxal is essential.

All patients should be aware of the absolute and relative contraindications. Safety is a priority, particularly regarding interactions with other medications or underlying health conditions.

High-Risk Groups (Elderly, Pregnancy, Chronic Illness)

Specific demographics face heightened risks when considering Androxal. The elderly may have multiple comorbidities that complicate treatment. For pregnant women, the teratogenic risk associated with enclomifene poses significant concerns. Patients with chronic illnesses like severe hepatic impairment should approach this medication cautiously, as its safety profile remains unestablished in these groups.

Interaction with Activities (Driving, Workplace Safety Under Australian Law)

Taking Androxal can lead to side effects such as headache, nausea, and mood swings. These side effects may impair one's ability to drive or operate machinery, which is a significant concern under Australian law. It is important for patients to assess their well-being before engaging in activities that require full alertness.

Q&A - “Can I Drive After Taking It in Australia?”

Generally, if you feel any adverse effects from Androxal, such as dizziness or drowsiness, it’s best to avoid driving. It’s crucial to consult with a healthcare provider to understand your individual risks before making any decisions regarding driving or working in safety-sensitive environments.

Mechanism & Pharmacology

Simplified explanation

Enclomifene, commonly known as Androxal, functions by blocking the effects of estrogen in the body. This specific action classifies it as an estrogen receptor antagonist.

When enclomifene binds to the estrogen receptors in the hypothalamus, it disrupts the normal feedback loop that estrogen has on hormone production. This disruption leads to an increased secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH).

The boost in these hormones stimulates the testes to produce more testosterone, making enclomifene particularly significant in treating male hypogonadism.

Clinical terms

The term "estrogen receptor antagonist" might sound complex. In simple terms, it means that enclomifene blocks estrogen from exerting its effects in the body. This is crucial because when estrogen levels are high in men, they can inhibit testosterone production.

It’s also labelled as a gonadotropin stimulant, which is a fancy way of saying it helps encourage the glands that produce hormones necessary for sexual function and fertility.

Indications & Off-Label Uses

Approved indications by TGA

The Therapeutic Goods Administration (TGA) in Australia acknowledges enclomifene for treating certain hormonal issues related to male infertility, specifically secondary hypogonadism. In this situation, men have low testosterone levels due to inadequate stimulation from the pituitary gland, leading to diminished sexual function.

Off-label uses in Australian clinical practice

While enclomifene is primarily approved for specific hormonal deficiencies, some Australian doctors have observed potential benefits in off-label applications. For example, it has been used to help men experiencing testosterone suppression due to weight loss or lifestyle changes.

Additionally, anecdotal evidence suggests some practitioners have explored its use in the management of testosterone levels in men who would prefer not to undergo traditional testosterone replacement therapy.

Key Clinical Findings

Recent studies from 2022 to 2025 focusing on Androxal demonstrate its efficacy in increasing endogenous testosterone levels and improving fertility in men with hypogonadism.

One prominent study highlighted that men taking enclomifene had a substantial rise in serum testosterone, comparable to traditional testosterone replacement therapies.

Participants also reported improvements in mood and sexual function, suggesting that enclomifene could enhance quality of life in men dealing with low testosterone levels.

Moreover, a 2023 study found minimal side effects, indicating that enclomifene could be a safer option for men wary of conventional hormone treatments.

Further investigation is warranted to explore these findings more comprehensively, as ongoing research continues to unveil the full potential of Androxal.

Alternatives Matrix

PBS-listed alternatives comparison table

Pros and cons checklist

Guidelines for Proper Use

Australian pharmacist counselling style

When it comes to discussing enclomifene, effective communication is essential. Pharmacists are expected to engage in clear and supportive conversations with patients, addressing their concerns about the medication. The following points should always be highlighted:

• Empathy and Understanding: Patients may have fears or misconceptions about enclomifene. A pharmacist should take the time to listen and reassure them.
• Clarification of Use: It is important for the pharmacist to clarify that enclomifene is not currently approved for general medical use in Australia and is mainly being studied for conditions like male hypogonadism.
• Information on Side Effects: Patients should be made aware of potential mild to moderate side effects, including headaches and mood changes, which can occur.
• Support for Questions: Encourage patients to ask questions about their treatment plan and provide thorough answers to empower them in their decisions.

Overall, the pharmacist’s role is pivotal in ensuring patients leave with a good understanding of enclomifene, its potential benefits, and associated risks.

Patient advice from PBS and national health authorities

The Pharmaceutical Benefits Scheme (PBS) and national health authorities have provided essential guidelines for the use of medications like enclomifene. While this drug is not currently available for general use, the following points summarise valuable advice that patients should keep in mind:

• Consult Your Healthcare Provider: Always discuss any concerns or medication adjustments with a healthcare provider before making changes.
• Understand Prescribing Information: Patients should be made aware that enclomifene may only be available through special arrangements, like investigational studies.
• Monitor Symptoms: It’s crucial for patients to report any unusual side effects to their pharmacist or doctor immediately.
• Drug Interactions: Patients should inform their pharmacists about any other medications they are taking to avoid potential interactions.

These guidelines emphasise the importance of proactive healthcare management and encourage open dialogue between patients and their healthcare professionals.

Delivery Overview for Enclomifene