NCT02855346

PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel

A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of Dapivirine/Levonorgestrel Vaginal Rings

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel

Detailed description

A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of Dapivirine/Levonorgestrel

Conditions

• HIV Prevention

Interventions

Type	Name	Description
COMBINATION_PRODUCT	200 mg of DPV + 320 mg LNG	DPV VR, containing 200 mg DPV
COMBINATION_PRODUCT	200 mg of DPV	DPV-LNG VR, containing 200 mg of DPV + 320 mg LNG

Timeline

• Start date: 2017-05-03
• Primary completion: 2017-08-18
• Completion: 2017-08-18
• First posted: 2016-08-04
• Last updated: 2018-05-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study