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An Open-label, Parallel-group Pharmacokinetic Trial in Healthy HIV-negative Women to Characterize the Release Profile of Dapivirine Delivered by a Silicone Matrix Ring (Ring 004), Containing 25 mg of Dapivirine, Over Various Ring Use Periods
Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring containing 25 mg worn for 1, 2, 4, 8 or 12 months.
Details
| Lead sponsor | International Partnership for Microbicides, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2013-11 |
| Completion | 2014-05 |
Conditions
- Pharmacokinetics
Interventions
- dapivirine ring
Primary outcomes
- dapivirine pharmacokinetics in plasma — 1,2,4,8 or 12 weeks