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Study of Dapivirine Vaginal Ring (VR) in Adolescents

NCT02028338 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-10-24

Study results available
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Summary

To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-week of study product use.

Conditions

  • Human Immunodeficiency Virus

Interventions

COMBINATION_PRODUCT

placebo ring

intravaginal ring silicone elastomer intravaginal ring containing no drug product

COMBINATION_PRODUCT

dapivirine ring

intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine

Sponsors & Collaborators

  • Microbicide Trials Network

    collaborator NETWORK

  • National Institutes of Health (NIH)

    collaborator NIH

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-27
Primary Completion
2016-07-05
Completion
2018-06-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT02028338 on ClinicalTrials.gov