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A Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine

NCT02858024 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-09-06

No results posted yet for this study

Summary

A Two-Cohort, Open-Label, Randomised, Three-Period Crossover Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine

Conditions

Interventions

DRUG

Dapivirine Vaginal Ring-004 and no tampons

Dapivirine Vaginal Ring-004 for 28 days, with menses, no tampon use (Treatment A),

DRUG

Dapivirine Vaginal Ring-004 with tampons

followed by Dapivirine Vaginal Ring-004 for 28 days, with menses, with tampon use (Treatment B)

DRUG

Dapivirine Vaginal Ring-004 with no menses

Dapivirine Vaginal Ring-004 for 28 days, with no menses occurring (Treatment E; treatment period 3).

DRUG

Dapivirine Vaginal Ring-004 and same ring inserted after menses

Dapivirine Vaginal Ring-004 used continuously until the start of menses, at which time the ring will be removed, and the same ring re-inserted five days later (estimated completion of menses) (Treatment C)

DRUG

Dapivirine Vaginal Ring-004 and new ring inserted after menses

Dapivirine Vaginal Ring-004 used continuously until the start of menses, at which time the ring will be removed, and a new ring inserted five days later (estimated completion of menses) (Treatment D)

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-01-12
Primary Completion
2016-04-16
Completion
2016-04-16

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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 NCT02858024 on ClinicalTrials.gov