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Intra-vaginal testosterone (IVT) is a potential treatment for vulvovaginal atrophy (VVA) associated with aromatase inhibitor (AI) use. To investigate the effects of IVT on sexual satisfaction, vaginal symptoms and urinary incontinence (UI) associated with AI use. Double-blind, randomized, placebo-controlled trial. Academic clinical research centre. Postmenopausal women taking an AI with VVA symptoms. IVT cream (300mcg/dose) or identical placebo, self-administered daily for 2 weeks and then thrice weekly for 24 weeks. The primary outcome was the change in the sexual satisfaction score of the Female Sexual Function Index (FSFI). Secondary outcomes included vaginal symptoms and responses to the Profile of Female Sexual Function (PFSF), the Female Sexual Distress Scale-Revised (FSD-R) and the Questionnaire for UI Diagnosis (QUID). Serum sex steroids were measured. 44 women were randomized and 37 provided evaluable data, (mean age, 56.4 [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 versus placebo (mean difference 0.73 units, 95%CI 0.02-1.43, p=0.043). IVT cream resulted in significant improvements, versus placebo, in FSD-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. IVT significantly improved sexual satisfaction and reduced dyspareunia in postmenopausal women on AI therapy. The low reporting of UI amongst women on AI therapy merits further investigation. |
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