Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring (TDF IVR-002)
Status:Stopped Early
Phase:I
Principal Investigator(s):Marla J Keller, MD
Objective:This prospective, two-site, two-arm, randomized, single-blind, placebo-controlled trial will examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate (TDF) vaginal ring when used continuously for 84 consecutive days by sexually active women.
The primary objective is to assess the safety of TDF vaginal rings when used continuously for 84 days by healthy, HIV-uninfected, sexually active women, as compared with a placebo vaginal ring.
Prevention Option(s):Microbicides
Study Design:Blind, Randomized
Arms and Assigned Interventions
DescriptionThe TDF vaginal ring is a flexible torus-shaped device with an inner core that contains the experimental drug, TDF. The ring is worn for 28 days at a time and changed every 28 days for total of 3 months.
Mode of DeliveryRing
ARMsExperimental
Official Code:
NCT02762617
Trial Sponsors:
Albert Einstein College of Medicine of Yeshiva University
Start Date
End Date
January 5, 2017
December 5, 2018
Enrollment:80
Age range:
18 Years ↔
45 Years
Population:Cisgender Women