NCT03467347

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

A Randomized, Phase 1, Open-Label Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety and Bleeding Patterns Associated With 90-Day Use of Matrix Vaginal Rings Containing 200 mg Dapivirine and 320 mg Levonorgestrel

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I single-center, two-arm, open-label, randomized study in healthy HIV-negative women to evaluate the pharmacokinetics, safety, and bleeding patterns associated with 90-day use of matrix vaginal rings containing 200 mg Dapivirine and 320 mg Levonorgestrel.

Detailed description

This 26 week study will be conducted at one site. The site will enroll 24 subjects. Subjects will be randomized to 1 of 2 treatment regimens: Regimen A: vaginal ring used continuously for approximately 90 days Regimen B: vaginal ring used cyclically for approximately 90 days: used for \~28 days, then removed,washed and stored for 2 days. The same ring will be used for 2 additional cycles in a similar fashion.

Conditions

• Healthy
• Contraception
• Contraceptive Usage
• Women

Interventions

Type	Name	Description
DRUG	VR: 200 mg DPV + 320 mg LNG	One silicone elastomer vaginal ring (VR) containing the active ingredients dapivirine (DPV) and levonorgestrel (LNG), formulated as IPM VR: 200 mg DPV + 320 mg LNG (Ring-102)

Timeline

• Start date: 2018-07-17
• Primary completion: 2019-08-30
• Completion: 2019-10-07
• First posted: 2018-03-16
• Last updated: 2019-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study