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CONRAD A13-128

Status
Completed
Phase
I
Principal Investigator(s)
Jill Schwartz & Chris Mauck
Objective

To evaluate the:

  • safety of the TFV/LNG, and TFV-only intravaginal rings
  • pharmacokinetics of TFV and lNG
  • acceptability of intravaginal rings

 

Last updated May 16, 2021

Prevention Option(s)
Microbicides
Study Design
Controlled
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
TFV ring
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
TFV/LNG ring
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
Trial Sponsors
CONRAD
October 2014
December 2015
Enrollment
86
18
Years
45
Years
Population
Women
Sites

Eastern Virginia Medical School

Norfolk, Virginia
United States of America

Profamilia

Santo Domingo
Dominican Republic