Characterization of Women Who Experienced Urinary Tract Infections in the Phase 3 AMPOWER Trial [A15]

INTRODUCTION: Vaginal pH modulator (VPM; Phexxi) is a non-hormonal, on-demand, woman-controlled gel for the prevention of pregnancy. The objective of this post-hoc analysis was to characterize women who experienced urinary tract infections (UTIs) while receiving VPM in the AMPOWER trial. METHODS: AMPOWER was a phase 3, single-arm, multicenter (112 sites) study that evaluated the contraceptive efficacy/safety of VPM over 7 cycles of use in sexually active women 18-35 years old (NCT03243305; Thomas et al. Contraception 2020). Exclusion criteria included ≥3 UTIs in the past year or an active UTI at screening. In the post-hoc analysis, women who experienced an on-study UTI were assessed by demographic characteristics and by reports of product use and sexual intercourse. RESULTS: Of the 1339 women who administered at least one dose of VPM and were included in the safety population, 77 (5.7%) experienced an on-study UTI. Demographic characteristics of these women were as follows: mean age, 28.1 years; mean body mass index, 28.3 kg/m2; race, 75.3% White, 20.8% Black/African American, 3.9% other; ethnicity, 57.1% non-Hispanic/Latino, 42.9% Hispanic/Latino. In the cycles in which a UTI was diagnosed/reported, the mean number of all acts of intercourse was 3.4 (standard deviation [SD], 3.8) and the mean number of acts of intercourse with product use was 3.2 (SD, 3.7). By comparison, the mean number of product uses per cycle in the overall population was 4.24. CONCLUSION: Compared to the overall AMPOWER population, women who experienced on-study UTIs had similar baseline characteristics and slightly lower product use.