CONRAD B17-144

Status:Ongoing
Phase:II
Principal Investigator(s):
Objective:The purpose of the study is to evaluate the safety, pharmacokinetics and pharmacodynamics of, and the tolerability and acceptance of an intravaginal ring (IVR) delivering both tenofovir and levonorgestrel (TFV/LNG) and an IVR delivering TFV only, compared to a placebo IVR, in women in Western Kenya.   Last updated April 30, 2021
Prevention Option(s):Microbicides, MPTs
Study Design:Randomized
Arms and Assigned Interventions
DescriptionTFV/LNG IVR is an intravaginal ring that releases approximately 8-10 mg/day of TFV and approximately 20ug/day of LNG to be used for 90 continuous days.
Mode of DeliveryRing
ARMsExperimental
DescriptionFV IVR is an intravaginal ring that releases approximately 8-10mg/day of TFV to be used for 90 continuous days
Mode of DeliveryRing
ARMsExperimental
Official Code: NCT03762382
Related Publications:
Randomized, placebo controlled phase I trial of safety, pharmacokinetics, pharmacodynamics and acceptability of tenofovir and tenofovir plus levonorgestrel vaginal rings in women
Start Date
End Date
December 6, 2018
April 2, 2020
Enrollment:50
Age range: 18 Years ↔ 34
Population:Cisgender Women