Trials / Completed
CompletedNCT01548560
Assessing the Safety of Dapivirine Gel and Film Formulations
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- International Partnership for Microbicides, Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This is a study to determine the safety of dapivirine gel and dapvirine film for healthy, HIV-uninfected women aged 18-45 years using the product for 7 daily doses.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dapivirine Vaginal Film | Dosage form: vaginal film Dosage: 1.25mg Frequency: 7 daily doses |
| DRUG | Dapivirine Vaginal Gel | Dosage form: vaginal gel Dosage: 0.5%, 2.5g Frequency: 7 daily doses |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2014-02-01
- Completion
- 2014-02-01
- First posted
- 2012-03-08
- Last updated
- 2017-09-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01548560. Inclusion in this directory is not an endorsement.