NCT05041699

PK, Safety Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel

A Randomized, Double-Blind, Phase 1b Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety, and Bleeding Patterns Associated With 90-Day Use of Core-Sheath Vaginal Rings Releasing Dapivirine and Levonorgestrel

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A double-blind, randomized trial (1:1) to characterize the local and systemic pharmacokinetics (PK) of two DPV-LNG vaginal ring formulations

Detailed description

A Randomized, Double-Blind, Phase 1b Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety, and Bleeding Patterns Associated with 90-Day Use of Core-Sheath Vaginal Rings Releasing Dapivirine and Levonorgestrel

Conditions

• Pharmacokinetics
• Safety Issues
• Bleeding

Interventions

Type	Name	Description
COMBINATION_PRODUCT	IPM Ring-105	DPV-LNG Ring containing xx mg of dapivirine + xx mg of levonorgestrel
COMBINATION_PRODUCT	IPM Ring-106	DPV-LNG Ring containing xx mg of dapivirine + xx mg of levonorgestrel

Timeline

• Start date: 2022-06-20
• Primary completion: 2024-10-07
• Completion: 2024-10-07
• First posted: 2021-09-13
• Last updated: 2026-04-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study