Testosterone Therapy in Women: Current Evidence and Recommendations
Testosterone therapy for women has limited evidence supporting its use, with data primarily available for postmenopausal women with hypoactive sexual desire disorder, while safety data beyond 2 years are lacking.
Current Evidence Base
The evidence for testosterone therapy in women is primarily limited to specific clinical scenarios:
- Postmenopausal women with hypoactive sexual desire disorder (HSDD): Most research has focused on this population 1, 2
- Premenopausal women: Limited data exists to support testosterone use in this population 3
- Women with premature ovarian insufficiency (POI): Some evidence suggests potential benefit 4
Indications with Supporting Evidence
Sexual Function
- Testosterone therapy has shown positive effects on sexual function, primarily desire, arousal, and orgasmic response in postmenopausal women 2
- The International Society for the Study of Women's Sexual Health recommends systemic transdermal testosterone for women with HSDD not primarily related to modifiable factors or comorbidities 1
Androgen Deficiency States
Testosterone therapy may be considered in:
- Women with hypothalamic amenorrhea
- Premature ovarian failure
- Post-oophorectomy
- Adrenal insufficiency
- Hypopituitarism 3
Safety Considerations
Short-term Safety (up to 2 years)
- Common side effects include mild and reversible acne and hirsutism 5, 2
- Changes to lipid profile with oral, but not transdermal testosterone 5, 6
- No evidence of increased hepatotoxicity, endometrial hyperplasia, or behavioral hostility 5
Long-term Safety Concerns
- Long-term safety data (beyond 2 years) are lacking 5, 1
- Insufficient data regarding:
- Cardiovascular risk
- Breast cancer risk
- Thromboembolic events 2
Dosing and Administration
Preferred Formulations
- Transdermal patches and topical gels/creams are preferred over oral products due to first-pass hepatic effects with oral formulations 2
- Government-approved transdermal male formulations can be used cautiously with dosing appropriate for women 1
- Custom-compounded products are not recommended due to inconsistent dosing 1, 2
Monitoring
- Baseline total testosterone level should be measured before initiating therapy 1, 2
- Monitor for signs of androgen excess (acne, hirsutism)
- Maintain testosterone concentrations in the physiologic premenopausal range 1
- Monitor lipid profile, particularly HDL cholesterol 6
- Regular assessment of subjective sexual response, desire, and satisfaction 2
Special Populations
Premenopausal Women
- Very limited data exists for testosterone therapy in premenopausal women 3
- May be considered in specific clinical circumstances with documented testosterone deficiency 3
Women with Breast Cancer History
- Testosterone therapy is contraindicated in women with breast or uterine cancer 2
- The FDA label for testosterone products warns against use in women with known or suspected breast cancer 7
Clinical Pitfalls to Avoid
Inappropriate diagnosis: Laboratory testing of testosterone levels should not be used to diagnose testosterone insufficiency but only to monitor for supraphysiologic levels 2
Excessive dosing: Using testosterone products formulated for men without appropriate dose adjustment can lead to virilization 7
Extended duration: Testosterone therapy should be administered at the lowest dose for the shortest time that meets treatment goals 2
Ignoring contraindications: Testosterone is contraindicated in women with breast or uterine cancer or cardiovascular or liver disease 2
Overlooking concomitant estrogen: Testosterone treatment without concomitant estrogen therapy is not recommended due to lack of evidence 2
Conclusion
While testosterone therapy shows promise for specific indications in women, particularly for sexual dysfunction in postmenopausal women, the evidence base remains limited. Clinicians should carefully weigh potential benefits against unknown long-term risks and ensure appropriate monitoring if testosterone therapy is prescribed.