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Safety and Adherence of a Non-medicated Intravaginal Ring (IVR)

NCT01268332 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2017-08-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of and adherence to a non-medicated IVR in HIV uninfected women over 12 weeks of use.

Conditions

  • Healthy

Interventions

DRUG

Non-medicated Intravaginal Ring

Cured silicone elastomer composed of an elastomer base, normal propylorthosilicate, and titanium dioxide. The ring will not contain an active pharmaceutical ingredient.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Microbicide Trials Network

    collaborator NETWORK

  • Population Council

    lead OTHER

Principal Investigators

  • Craig Hoesley, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-09-30
Completion
2013-03-07

Countries

  • United States
  • India

Study Locations

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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 NCT01268332 on ClinicalTrials.gov