This multi-center Phase I study is designed to characterize the safety, PK, and PD of TFV/LNG IVR to assess systemic and genital tract bioavailability in healthy women. The IVRs to be used in the study are TFV/LNG IVR (8-10mg per day/20μg per day) or placebo IVR. Samples will be obtained before, during and after 90 days of continuous or interrupted IVR use.
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Percentage of women with Treatment-emergent adverse events
Timeframe: Day 90
Changes in systemic laboratory values
Timeframe: Change from Baseline at Day 90
Changes in cervicovaginal mucosa by visual inspection
Timeframe: Change from Baseline at Day 90
Changes in soluble markers
Timeframe: Change from Baseline at Day 90
Changes in inflammatory markers in cervicovaginal tissue
Timeframe: Change from Baseline at Day 90
Changes in endogenous vaginal bacteria
Timeframe: Change from Baseline at Day 90
Microbial growth
Timeframe: Day 90