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Status
Completed
Phase
I
Principal Investigator(s)
Patrick Kiser, PhD
Objective
The purpose of the study is to evaluate the safety of the TFV/LNG intravaginal ring (IVR), TFV-only IVR, and placebo IVR, evaluate pharmacokinetics (PK) of TFV and LNG, evaluate pharmacodynamic (PD) surrogates of contraceptive efficacy of LNG, and to evaluate acceptability of the IVRs.
Prevention Option(s)
Microbicides
Multipurpose Prevention Technologies
Study Design
Randomized
Double-blind
Arms and Assigned Interventions
Description
TFV IVR is an intravaginal ring 55.0 mm in diameter, consisting of single segment of polyurethane tubing with an outer diameter of 5.5 mm and filled with white TFV-containing paste. Used for one month, the IVR delivers 8-10 mg/day TFV.
Mode of Delivery
Ring
Products
tenofovir
ARMs
Experimental
Description
TFV/LNG IVR is an intravaginal ring 55.0 mm in diameter, consisting of two segments of polyurethane tubing with an outer diameter of 5.5 mm: a longer segment containing white TFV paste and a shorter one (20 mm) with a white LNG core. Used for one month, the IVR delivers 8-10 mg/day TFV and 20 μg/day LNG.
Mode of Delivery
Ring
Products
Levonorgestrel
tenofovir
ARMs
Experimental
Description
Intravaginal ring 55.0 mm in diameter, consisting of two segments of polyurethane tubing with an outer diameter of 5.5 mm containing no active experimental ingredients. Used for one month.
Mode of Delivery
Ring
ARMs
Placebo Comparator
Official Code
Trial Sponsors
CONRAD
October 2014
December 2015
Enrollment
86
18
Years
45
Years
Population
Women
Sites
Profamilia
Santo Domingo
Dominican Republic
Eastern Virginia Medical School
Norfolk, Virginia
United States of America