What is the recommended dosing for Androgel (testosterone) 1% in a postmenopausal female with Hypoactive Sexual Desire Disorder (HSDD)?

Testosterone Dosing for Postmenopausal Women with HSDD

AndroGel 1% is not FDA-approved for use in postmenopausal women with HSDD, and there are no established dosing guidelines for this off-label use.

Current Treatment Options for HSDD in Postmenopausal Women

FDA-Approved Medications

• While flibanserin is FDA-approved only for premenopausal women with HSDD, evidence supports its efficacy in postmenopausal women as well 1
• The PLUMERIA study demonstrated that flibanserin was generally well-tolerated and showed improvement in sexual desire in postmenopausal women with HSDD 2

Testosterone Therapy for HSDD

• Testosterone is considered an evidence-based therapy for HSDD in postmenopausal women, though not FDA-approved for this indication 3
• When using testosterone off-label for postmenopausal women with HSDD:
  • Target physiologic testosterone levels for premenopausal women
  • Monitor for androgenic side effects
  • Evaluate efficacy after 3-6 months
  • Discontinue if no improvement in symptoms

Off-Label Testosterone Dosing Considerations

When using AndroGel 1% off-label for postmenopausal women with HSDD:

1. Starting dose: Begin with a very low dose - approximately 1/10th of the male dose

   • Apply approximately 0.5g of AndroGel 1% (delivering about 5mg testosterone) daily
   • Apply to clean, dry skin of upper arms, shoulders, or abdomen

2. Titration:

   • Monitor free testosterone levels every 3 months
   • Target the upper range of normal for premenopausal women
   • Adjust dose based on clinical response and testosterone levels
   • Maximum dose should not exceed 1g of AndroGel 1% daily

3. Monitoring:

   • Measure baseline and follow-up free and total testosterone levels
   • Monitor for androgenic side effects (acne, hirsutism, voice changes)
   • Check lipid profiles and liver function tests every 3 months 4
   • Assess clinical response using validated sexual function questionnaires

Important Considerations and Cautions

• Long-term safety data on testosterone use in women is limited 5

• Testosterone therapy should be discontinued if:

  • No improvement in sexual function after 6 months
  • Development of significant androgenic side effects
  • Abnormal laboratory values

• Alternative options to consider before testosterone:

  • Non-hormonal moisturizers and lubricants for vaginal dryness 6
  • Bupropion or buspirone (off-label) for HSDD 1
  • For vaginal symptoms, estriol-containing vaginal preparations may be preferred over estradiol due to lower systemic absorption 1, 6

Clinical Pearls

• Testosterone prescribing for HSDD shows significant variability in duration, route, and co-administration with estrogen 7
• Local testosterone application has shown efficacy in case reports with minimal side effects when properly monitored 4
• Underprescription of testosterone for HSDD remains common despite evidence supporting its use 7
• The sole evidence-based indication for testosterone therapy in women is HSDD in postmenopausal women 3

Remember that while testosterone may be effective for HSDD, patients must be informed about the off-label nature of this treatment and the limited long-term safety data available.