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

2018-03-22 01:55:16 | BioPortfolio

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.

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

Conditions

Healthy

Intervention

VR: 200 mg DPV + 320 mg LNG

Status

Not yet recruiting

Source

Health Decisions

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-03-22T01:55:16-0400

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