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CONRAD B17-144

Status
Ongoing
Phase
II
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
Multipurpose Prevention Technologies
Study Design
Randomized
Arms and Assigned Interventions
Description
TFV/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 Delivery
Ring
Products
TFV/LNG ring
ARMs
Experimental
Description
FV IVR is an intravaginal ring that releases approximately 8-10mg/day of TFV to be used for 90 continuous days
Mode of Delivery
Ring
Products
TFV ring
ARMs
Experimental
Description
Placebo IVR is an intravaginal ring containing no active experimental ingredients to be used for 90 continuous days.
Mode of Delivery
Ring
ARMs
Placebo Comparator
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
December 2018
April 2020
Enrollment
50
18
Years
34
Population
Women
Sites

Kenya Medical Research Institute

Kenya