Trials / Completed
CompletedNCT01277640
Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- International Partnership for Microbicides, Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine the safety of male genitalia when exposed to dapivirine gel following seven once daily applications.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dapivirine | * dosage form: gel 0.05% * dosage: 2.5g * frequency: once daily * duration: 7 days |
| DRUG | matched placebo | * dosage form: gel, no api * dosage: 2.5g * frequency: once daily * duration: 7 days |
| DRUG | universal placebo | * dosage form: gel, HEC-based * dosage: 2.5g * frequency: once daily * duration: 7 days |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2011-01-17
- Last updated
- 2017-09-08
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01277640. Inclusion in this directory is not an endorsement.