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IPM 056 / CCN019B

Status
Ongoing
Phase
I/II
Principal Investigator(s)
John Steytler
Objective


A Randomized, Double-Blind, Phase 1b Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety, and Bleeding Patterns Associated With 90-Day Use of Core-Sheath Vaginal Rings Releasing Dapivirine and Levonorgestrel

Last updated September 23, 2022

Prevention Option(s)
Multipurpose Prevention Technologies
PrEP
Study Design
Randomized
Double-blind
Arms and Assigned Interventions
Description
Arm Intervention/treatment Experimental: IPM Ring-105 Ring-105 (xx mg dapivirine + xxx mg levonorgestrel)
Mode of Delivery
Ring
Products
Dapivirine-Levonorgestrel ring
ARMs
Experimental
Description
Active Comparator: IPM Ring-106. Ring-106 (xx mg dapivirine + xxx mg levonorgestrel)
Mode of Delivery
Ring
Products
Dapivirine-Levonorgestrel ring
ARMs
Active Comparator
Trial Sponsors
IPM, NICHD, NIH
June 2022
September 2023
Enrollment
40
18
Years
45
Days
Population
Women
Sites

Oregon Health & Science University

Portland, Oregon
United States of America

Magee Women's Hospital of UPMC

Pittsburgh
United States of America