Trials / Completed
CompletedNCT02808949
Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women
Phase 1 Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- Sponsor
- International Partnership for Microbicides, Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
Phase 1 PK Study of the Dapivirine Vaginal Ring in Lactating Women.
Detailed description
PK Study of the Dapivirine Vaginal Ring in Lactating Women.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dapivirine | Participants will receive a silicone elastomer vaginal matrix ring containing 25 mg of dapivirine to wear for approximately 14 continuous days. Participants age 18 and over, at least 6 weeks postpartum, able to produce and express breast milk for 14 consecutive days. |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2018-03-03
- Completion
- 2018-03-03
- First posted
- 2016-06-22
- Last updated
- 2018-03-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02808949. Inclusion in this directory is not an endorsement.