(002) The Effects of Vaginal Testosterone versus Placebo on Female Sexual Function: Interim Analysis of the PIVoT Trial (Prevention of Recurrent Urinary Tract Infection using Vaginal Testosterone)

Abstract

Abstract Introduction Post-menopasual women experience changes in vaginal flora and vaginal atrophy that have been associated with declining estrogen levels. These changes to the vaginal microenvironment often lead to significant genital pain and discomfort during sexual intercourse. Vaginal estrogen treats atrophy thereby restoring flora, which prevents UTIs and improves sexual function in post-menopausal women. While estrogen is effective, some patients have contraindications or are unwilling to use it. Vaginal testosterone cream (VT) has been shown to improve vaginal atrophy, however, its effects on overall vaginal health and sexual function have not been fully described. Objective The purpose of this study was to determine if VT is more effective than placebo cream in restoring the vaginal flora, improving the vaginal health index (VHI), and the sexual function of postmenopausal women with recurrent UTIs. Methods This is an interim analysis of a randomized, double- blind placebo-controlled pilot study enrolling postmenopausal women with recurrent UTIs. Vaginal health index (VHI) and swab to assess flora via DNA sequencing were collected. Patients were randomized to VT or placebo. Female sexual function index (FSFI) questionnaires were administered at baseline, one month, and nine months post treatment. Results A total of 44 women have been enrolled. Average VHI at enrollment was 13.66 +/− 0.4. There was no difference in baseline characteristics among the groups. Results show an improvement in female sexual function index scores in both groups from baseline. In the VT arm, improvements were seen in the desire (2.18 to 2.85), lubrication (1.74 to 2.175), orgasm (1.64 to 2.5) and pain (0.91 to 1.3) domains of the FSFI. Interestingly, improvements in all domains were seen in the placebo group, however, more patients in this group reported being sexually active. In terms of VHI, there was a statistically significant increase in VHI scores at 9 months post-treatment with VT (14.65 +/−4.20 to 17.50 +/− 4.43, p = 0.04). This increase in vaginal health index was not observed in the placebo arm. Conclusions Initial data demonstrates improvement in vaginal pH and VHI after 9 months of treatment with VT. Improvement in sexual function scores were also seen in both the treatment and the placebo groups. Higher patient enrollment and longer treatment follow up will be valuable in understanding the effects of VT versus placebo on sexual function among postmenopausal women. Disclosure No