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

Healthy Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03467347
Study type Interventional
Source International Partnership for Microbicides, Inc.
Contact
Status Completed
Phase Phase 1
Start date July 17, 2018
Completion date October 7, 2019
View Details
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