PK Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel
Status:
Completed
Trial end date:
2019-10-07
Target enrollment:
Participant gender:
Summary
This is a Phase I single-center, two-arm, open-label, randomized study in healthy
HIV-negative women to evaluate the pharmacokinetics, safety, and bleeding patterns associated
with 90-day use of matrix vaginal rings containing 200 mg Dapivirine and 320 mg
Levonorgestrel.
Phase:
Phase 1
Details
Lead Sponsor:
International Partnership for Microbicides, Inc.
Collaborators:
Division of AIDS, US National Institute of Allergy and Infectious Diseases Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Mental Health (NIMH) National Institutes of Health (NIH)