Is Androgel (testosterone) suitable for treating menopausal symptoms in women?

Androgel (Testosterone) for Menopausal Symptoms in Women

Androgel (testosterone) is not FDA-approved for treating menopausal symptoms in women and should not be used as first-line therapy for menopausal symptoms due to limited safety data and potential risks. 1

Current Guidelines on Testosterone Use in Menopausal Women

Indications and Limitations

• Testosterone therapy may be considered only for carefully selected postmenopausal women with hypoactive sexual desire disorder (HSDD) after other contributors to sexual dysfunction have been addressed 2
• The NCCN guidelines (2024) mention androgens as one of several discussion options for low desire or libido issues in menopausal women, but do not specifically recommend Androgel 3
• Testosterone is not FDA-approved for use in women, raising significant safety concerns about off-label prescribing 2, 4

Specific Menopausal Symptoms That May Respond to Testosterone

• Primarily indicated for hypoactive sexual desire disorder (HSDD) in postmenopausal women 2, 5
• May have some benefit for vaginal symptoms when used in specific formulations (e.g., DHEA) 3
• Limited evidence for other menopausal symptoms such as hot flashes

Safety Concerns and Contraindications

Absolute Contraindications

• History of hormone-dependent cancers (breast, uterine) 1
• Active liver disease 3
• Unexplained vaginal bleeding 3
• Recent history of thromboembolism 1

Safety Issues

• Long-term safety data on testosterone use in women is lacking, particularly regarding:
  • Cardiovascular risk
  • Breast cancer risk
  • Endometrial effects 2
• Common adverse effects include hirsutism and acne 6
• Risk of supraphysiologic dosing with formulations designed for men 2, 4

Alternative Approaches for Menopausal Symptom Management

First-Line Options

• For vasomotor symptoms (hot flashes):
  • Non-hormonal pharmacologic treatments: SSRIs/SNRIs, gabapentin, clonidine 1
  • Lifestyle modifications: regular exercise, weight loss, stress reduction 1

For Vaginal Symptoms

• Topical vaginal therapies (OTC or prescription) 3
• Vaginal moisturizers and lubricants
• Ospemifene for dyspareunia in women without history of estrogen-dependent cancers 3
• Vaginal DHEA (prasterone) - FDA-approved for genitourinary syndrome of menopause 2

For Sexual Dysfunction

• Pelvic floor physical therapy 3
• Vaginal dilators for pain during sexual activity 3
• FDA-approved medications like flibanserin for HSDD 3

Practical Considerations

If Testosterone Is Considered

• Should only be used after other treatments have failed
• Requires careful monitoring:
  • Clinical response
  • Adverse effects
  • Laboratory values to avoid supraphysiologic dosing 2
• Transdermal patches or topical gels are preferred over oral formulations to avoid hepatic first-pass metabolism 5
• Usually administered with concomitant estrogen therapy 5

Monitoring Requirements

• Initial follow-up 8-10 weeks after treatment initiation
• Regular reassessment every 3-6 months
• Annual comprehensive assessment of risks and benefits 1

Conclusion

While testosterone may have a limited role in treating specific sexual symptoms in carefully selected postmenopausal women, Androgel specifically is not recommended for general menopausal symptom management due to safety concerns, lack of FDA approval for women, and the availability of safer alternatives with better evidence.