What is the role of Androgel (testosterone) in managing symptoms in perimenopausal women?

Role of Androgel (Testosterone) in Managing Perimenopausal Symptoms

Androgel (testosterone) is not recommended as a first-line therapy for perimenopausal women due to limited safety data and lack of FDA approval for this indication. 1

Current Evidence on Androgens in Perimenopause

Androgens, including testosterone, are believed to play important biological roles in women, particularly in regulating libido and sexual arousal. However, the evidence supporting their use in perimenopausal women is limited:

• Testosterone therapy has not been approved by the FDA for use in women due to uncertainties regarding effectiveness and long-term safety 2
• Most clinical guidelines do not specifically recommend Androgel for perimenopausal symptom management 1
• 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 1

Specific Indications Where Androgens May Be Considered

For perimenopausal women with specific sexual dysfunction symptoms:

1. Hypoactive Sexual Desire Disorder (HSDD):

   • Limited evidence suggests testosterone may improve sexual function in carefully selected women with HSDD 2
   • However, this should only be considered after other contributors to sexual dysfunction have been adequately addressed 2

2. Vaginal Symptoms:

   • Vaginal DHEA (dehydroepiandrosterone, a precursor to testosterone) has shown benefits for vaginal dryness and pain 3
   • Prasterone (DHEA) received FDA approval in 2016 for vaginal symptoms 3
   • An RCT of 441 survivors of breast or gynecologic cancer showed that vaginal DHEA led to significant improvements in sexual desire, arousal, pain, and overall sexual function 3

Safety Concerns and Contraindications

Significant safety concerns exist with testosterone therapy in women:

• Long-term effects on cardiovascular risk and breast cancer incidence are unknown 2
• Androgen therapy is associated with androgenic side effects, primarily acne 4
• Testosterone therapy is contraindicated in women with:
  • Hormone-dependent cancers 1
  • Active liver disease 1
  • Unexplained vaginal bleeding 1

Preferred Treatment Options for Perimenopausal Symptoms

Based on current guidelines, the following approaches are preferred over Androgel:

1. For Vasomotor Symptoms:

   • Hormone replacement therapy (estrogen with progestogen for women with intact uterus) is the most effective treatment 3
   • Non-hormonal options include SSRIs/SNRIs, gabapentin, and clonidine 1
   • Lifestyle modifications: weight loss, smoking cessation, limiting alcohol 3

2. For Vaginal Symptoms:

   • Vaginal moisturizers and lubricants 3
   • Vaginal estrogen (pills, rings, or creams) 3
   • Ospemifene for dyspareunia in women without history of estrogen-dependent cancers 3, 1
   • Pelvic floor physical therapy 3
   • Vaginal dilators for pain during sexual activity 3

3. For Sexual Desire Issues:

   • FDA-approved medications like flibanserin for HSDD in premenopausal women 3
   • CBT has been shown to improve sexual functioning in menopausal women 3

Monitoring Recommendations

If testosterone therapy is considered despite the limitations:

• Use the lowest effective dose for the shortest duration needed 2
• Regular monitoring of testosterone levels to avoid supraphysiologic dosing 2
• Regular clinical assessment for androgenic side effects (hirsutism, acne) 2, 4
• Initial follow-up 8-10 weeks after treatment initiation 1

Conclusion

While limited evidence suggests testosterone may improve sexual function in some perimenopausal women, particularly those with HSDD, the lack of FDA approval, limited long-term safety data, and availability of other evidence-based treatments make Androgel a non-preferred option for managing perimenopausal symptoms. For women with sexual dysfunction not responding to first-line therapies, a trial of low-dose testosterone therapy may be considered with careful monitoring and appropriate counseling about the limited safety data.