Is there an evidence-based indication for testosterone therapy in postmenopausal women?

Testosterone Therapy in Postmenopausal Women: Evidence-Based Indications

Testosterone therapy is indicated only for hypoactive sexual desire disorder (HSDD) in postmenopausal women, with no evidence supporting its use for prevention of chronic conditions. 1

Evidence for Testosterone Use in Postmenopausal Women

Approved Indications

• Testosterone therapy has evidence supporting its use specifically for hypoactive sexual desire disorder in postmenopausal women 1, 2
• No testosterone product has been FDA-approved specifically for women 3
• The FDA label for testosterone explicitly states it is not indicated for use in women due to lack of controlled evaluations and potential virilizing effects 4

Efficacy for Sexual Function

• Randomized trials have demonstrated improvement in sexual function with testosterone in postmenopausal women with HSDD, particularly after oophorectomy 5
• Multiple clinical trials in postmenopausal women with loss of libido have shown that adding testosterone to estrogen significantly improved multiple facets of sexual functioning including:
  • Libido and sexual desire
  • Arousal
  • Frequency of sexual activity
  • Sexual satisfaction 6

Lack of Evidence for Other Indications

• The U.S. Preventive Services Task Force (USPSTF) recommends against using hormone therapy for prevention of chronic conditions (Grade D recommendation) 7, 8
• Insufficient data exists to support testosterone use for:
  • Preserving or increasing bone mineral density
  • Reducing hot flashes
  • Increasing lean body mass
  • Improving general well-being 2

Safety Considerations

Potential Adverse Effects

• Testosterone therapy in women may cause:
  • Hirsutism and acne (though actual risks are not well defined) 2
  • Potential virilizing effects 4
  • Possible lipid profile changes requiring dose adjustment or discontinuation 4

Monitoring Requirements

• For women receiving testosterone therapy:
  • Initial follow-up at 3 months
  • Annual follow-up thereafter
  • Assessment should include blood pressure, weight, lipid profile, and symptom control 8
  • Laboratory testing should be used to monitor for supraphysiologic levels, not to diagnose testosterone insufficiency 2

Contraindications

• Testosterone therapy is contraindicated in women with:
  • Breast or uterine cancer
  • Cardiovascular disease
  • Liver disease 2
  • Active liver disease 8

Practical Recommendations

Administration Guidelines

• Testosterone is usually administered concomitantly with estrogen therapy due to lack of adequate safety and efficacy data on testosterone alone 5
• Transdermal patches and topical gels/creams are preferred over oral products to avoid first-pass hepatic metabolism 5, 2
• Androgen treatment should be limited to 24 months with evaluation at 3-6 months 8
• Women should be informed that androgen treatment has limited supporting data and unclear long-term health effects 8

Clinical Approach

• Before considering testosterone therapy:
  • Rule out causes not related to testosterone levels (physical and psychosocial factors, medications)
  • Ensure there is a physiologic cause for reduced testosterone levels (e.g., bilateral oophorectomy) 2
  • Counsel regarding potential risks and benefits 2

Important Caveats

• No specific testosterone level defines androgen deficiency in women 3
• Clinically available laboratory assays do not accurately detect testosterone concentrations at values typically found in women 2
• Custom-compounded products should be used with caution due to potentially inconsistent dosing 2
• Testosterone products formulated for men carry risk of excessive dosing 2

In conclusion, while testosterone therapy has demonstrated benefits for sexual function in postmenopausal women with HSDD, it lacks evidence for other indications and carries potential risks that require careful consideration and monitoring.