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Testosterone use in women

Dr Karen Magraith BMBS FRACGP - Past-President of the AMS

With increasing interest in the use of testosterone for women, fuelled by anecdotal reports on social media, patients may present requesting prescriptions for testosterone for a range of reasons. It is timely to reconsider the evidence base for efficacy of testosterone, and the guidelines for safe use.

The context of this discussion is for post-menopausal cis-gender women, and is separate from any consideration of gender affirming hormone therapy for trans or gender diverse people.

The closest we have to an Australian or international guideline is the Global Consensus Position Statement on the Use of Testosterone Therapy for Women endorsed by RANZCOG and the Endocrine Society of Australia. Clinicians are encouraged to read the Statement to obtain detailed information. 

Testosterone is not a routine component of menopausal hormone therapy. The only evidence-based indication for the use of testosterone in women is for the treatment of postmenopausal women who have hypoactive sexual desire disorder (HSDD).

Some points about testosterone prescribing in women include:

  • There is no statistically significant association between endogenous testosterone levels and sexual function in premenopausal women and available data for postmenopausal women also show no association. Testosterone levels peak in early adulthood and decline during the reproductive years. Menopause (unless surgical) does not itself cause a sudden drop in testosterone levels.
  • Libido and other elements of sexual function are multifactorial. Hormones are just one factor.
  • When assessing patients, consider general physical and mental health, medications (including SSRIs and SNRIs), lifestyle, relationship issues, and previous history of trauma or abuse. Offer treatment for vaginal dryness if present.
  • There are anecdotal reports that treatment with testosterone may improve mood, cognition and general well-being. However, this is not supported by RCT evidence. Testosterone has not been shown to be effective for treatment of mood disorders, ‘brain fog’ or fatigue.
  • The only evidence-based indication for prescribing testosterone is for treatment of low libido, specifically hypoactive sexual desire disorder in postmenopausal women. In practice this means very low libido which distresses the woman, when other contributing factors have been considered and treated as appropriate.
  • Testosterone is not currently indicated for bone or muscle health. Research is ongoing in this area.
  • Transdermal testosterone has a modest beneficial effect on libido in the majority of postmenopausal women treated for this indication.
  • Measurement of baseline total testosterone levels is recommended. This is usually only available by immunoassay which provides a rough estimate but not a precise level for women. Therefore, blood testing is not to diagnose ‘testosterone deficiency’, but to ensure levels are not above the upper reference range before starting therapy.
  • “Free” testosterone should not be used to make a diagnosis or to monitor blood levels during treatment.
  • Once on treatment, periodic measurement of testosterone levels is needed to ensure that levels stay in the physiological female reference range.
  • Patients should be counselled about side effects, which are uncommon if levels remain in the normal range. Side effects include hirsutism, acne, vocal changes and clitoromegaly.
  • When levels remain in the physiological reference range, testosterone appears to be safe for the breast and cardiovascular health. However, data are only available up to 48 months of follow up, and long-term safety is uncertain. Clinical trials of testosterone have generally excluded women with pre-existing cardiovascular disease or breast cancer.
  • There is a TGA registered female-specific formulation available in Australia, and following TGA Guidance, this should be prescribed, not products designed for males. Products designed for males have a high potential for inadvertent application of high doses. For clinicians outside of Australia, the Consensus Statement indicates that transdermal male formulations can be used ‘off label’ judiciously, with regular monitoring of blood testosterone concentrations.

Clinicians considering offering testosterone to their patients are advised to read the Global Consensus Position Statement. Other resources include the AMS webinar featuring Prof Susan Davis, and a podcast for patients presented by Jean Hailes.  

Clinicians should also be aware of the Council of Australian Therapeutic Advisory Groups position on off -label prescribing:

  1. If therapeutic alternatives are available to treat a particular condition, evidence about comparative clinical effectiveness, safety and cost-effectiveness between the off-label medicine and TGA-approved alternatives should be sought. The medicine with a demonstrated advantage in clinical effectiveness and/or safety and/or cost-effectiveness (in the relevant population and for the intended use) should be chosen.
  1. When a medicine is prescribed off-label, this should be made explicit, along with expansion of the associated uncertainties. Patients should be advised when there is a TGA approved alternative available and why the off-label use is being recommended. Discussion of financial cost implications and access issues is necessary and should occur prior to initiation of therapy. In addition, the level and quality of evidence available to support the use of a medicine off-label plays a role in the decision about the nature and documentation of the informed consent process.

Content created March 2024