Intravaginal Testosterone Improves Sexual Satisfaction and Vaginal Symptoms Associated With Aromatase Inhibitors.

Context: Intravaginal testosterone (IVT) is a potential treatment of vulvovaginal atrophy (VVA) associated with aromatase inhibitor (AI) use.

Objective: To investigate the effects of IVT on sexual satisfaction, vaginal symptoms, and urinary incontinence (UI) associated with AI use.

Design: Double-blind, randomized, placebo-controlled trial.

Setting: Academic clinical research center.

Participants: Postmenopausal women taking an AI with VVA symptoms.

Intervention: IVT cream (300 μg per dose) or identical placebo, self-administered daily for 2 weeks and then thrice weekly for 24 weeks.

Main Outcomes And Measures: The primary outcome was the change in the sexual satisfaction score on the Female Sexual Function Index (FSFI). Secondary outcomes included vaginal symptoms and responses to the Profile of Female Sexual Function, the Female Sexual Distress Scale-Revised (FSDS-R), and the Questionnaire for UI Diagnosis. Serum sex steroids were measured.

Results: A total of 44 women were randomly assigned and 37 provided evaluable data, (mean age 56.4 years, SD 8.8 years). At 26 weeks, the mean between-group difference in the baseline-adjusted change in FSFI satisfaction scores was significantly greater for the IVT group than the placebo group (mean difference 0.73 units; 95% CI, 0.02 to 1.43; P = 0.043). IVT cream resulted in significant improvements, compared with placebo, in FSDS-R scores (P = 0.02), sexual concerns (P < 0.001), sexual responsiveness (P < 0.001), vaginal dryness (P = 0.009), and dyspareunia (P = 0.014). Serum sex steroid levels did not change. Few women had UI symptoms, with no treatment effect.

Conclusion: IVT significantly improved sexual satisfaction and reduced dyspareunia in postmenopausal women on AI therapy. The low reporting of UI among women on AI therapy merits further investigation.