NCT02858024

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

• HIV

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-01-12
• Primary completion: 2016-04-16
• Completion: 2016-04-16
• First posted: 2016-08-08
• Last updated: 2017-09-06