PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel
Phase 1
Completed
- Conditions
- HIV Prevention
- Registration Number
- NCT02855346
- Lead Sponsor
- International Partnership for Microbicides, Inc.
- Brief Summary
PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel
- Detailed Description
A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of Dapivirine/Levonorgestrel
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
- Healthy women
Exclusion Criteria
- HIV infected women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Dapivirine and levonorgestrel concentrations in blood and Vaginal fluid 14 days To characterize the local and systemic pharmacokinetics of one dapivirine vaginal ring formulation and one dapivirine-levonorgestrel vaginal ring formulations used continuously for 14 days
- Secondary Outcome Measures
Name Time Method Grade 2 or higher Genitourinary adverse event and Grade 3 or higher adverse event as defined by DAIDS 14 days To evaluate the safety of one dapivirine vaginal ring formulation and one dapivirine-levonorgestrel vaginal ring formulations used continuously for 14 days
Trial Locations
- Locations (2)
University of Alabama Hospital
🇺🇸Birmingham, Alabama, United States
Magee Women's Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
University of Alabama Hospital🇺🇸Birmingham, Alabama, United States