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A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings

NCT03234400 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2019-01-29

No results posted yet for this study

Summary

Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, 25 mg, 100 mg or 200 mg VRs.

Conditions

Interventions

COMBINATION_PRODUCT

Dapivirine Vaginal Ring, 25 mg

Vaginal Ring containing 25 mg dapivirine

COMBINATION_PRODUCT

Dapivirine Vaginal Ring, 100 mg

Vaginal Ring containing 100 mg dapivirine

COMBINATION_PRODUCT

Dapivirine Vaginal Ring, 200 mg

Vaginal Ring containing 200 mg dapivirine

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

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
2017-12-04
Primary Completion
2018-10-23
Completion
2019-01-23
FDA Drug
Yes
FDA Device
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 NCT03234400 on ClinicalTrials.gov