CONRAD A13-128

Status:Completed
Phase:I
Principal Investigator(s):Jill Schwartz & Chris Mauck
Objective:First-in-woman, randomized, placebo controlled, double blind phase I trial to study the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of the tenofovir (TFV) intravaginal ring (IVR), the TFV/levonorgestrel (LNG) IVR or placebo IVR worn continuously over approximately 15 days of use Results summary: All IVRs were safe with the active ones delivering sustained high concentrations of TFV locally. LNG caused changes in cervical mucus, sperm penetration, and ovulation compatible with contraceptive efficacy. The TFV and TFV/LNG rings are ready for expanded 90 day clinical testing. Last updated October 18, 2022
Prevention Option(s):Microbicides
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionTFV 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 DeliveryRing
ARMsExperimental
DescriptionTFV/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 DeliveryRing
ARMsExperimental
Results: Randomized, placebo controlled phase I trial of safety, pharmacokinetics, pharmacodynamics and acceptability of tenofovir and tenofovir plus levonorgestrel vaginal rings in women
Official Code: NCT02235662
Related Publications:
Vaginal microbiota and mucosal pharmacokinetics of tenofovir in healthy women using tenofovir and tenofovir/levonorgestrel vaginal rings
Randomized, placebo controlled phase I trial of safety, pharmacokinetics, pharmacodynamics and acceptability of tenofovir and tenofovir plus levonorgestrel vaginal rings in women
Trial Sponsors: CONRAD
Start Date
End Date
October 1, 2014
December 1, 2015
Enrollment:86
Age range: 18 Years ↔ 45 Years
Population:Cisgender Women