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Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring

NCT02006264 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-28

Study results available
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Summary

This prospective, randomized, single-blinded, placebo controlled trial will examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate (TDF) vaginal ring when used continuously for 14 consecutive days.

The primary objective is to assess the safety of TDF vaginal rings when used continuously for 14 days by healthy, HIV-uninfected, sexually abstinent women, as compared with a placebo vaginal ring.

Conditions

Interventions

DRUG

TDF Intravaginal Ring

The TDF IVR intravaginal ring is formulated using flexible outer tubing, comprised of hydrophilic, aliphatic polyether urethane, and an inner core compartment comprised of 86% w/w TDF and 14% w/w sodium chloride (NaCl). The TDF intravaginal ring will be worn continuously for 14 days. It will be inserted into the vagina following cessation of participant's menses at Visit 3 and removed at Visit 7.

DRUG

Placebo Intravaginal Ring

The placebo ring is formulated using flexible outer tubing, comprised of hydrophilic, aliphatic polyether urethane, and an inner core comprised of sodium chloride (NaCl). The Placebo intravaginal ring will be worn continuously for 14 days. It will be inserted into the vagina following cessation of participant's menses at Visit 3 and removed at Visit 7.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Marla J Keller, MD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-19
Primary Completion
2014-11-06
Completion
2014-11-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02006264 on ClinicalTrials.gov