Trials / Completed
CompletedNCT01621399
Safety and Efficacy Study to Treat Bacterial Vaginosis
A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Product 55394 in the Treatment of Bacterial Vaginosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 651 (actual)
- Sponsor
- Medicis Global Service Corporation · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Product 55394 | Product 55394 vaginal gel in a prefilled applicator. |
| DRUG | Placebo Vehicle (non-treatment) | The vehicle vaginal gel in an applicator (placebo). |
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2012-10-01
- Completion
- 2012-12-01
- First posted
- 2012-06-18
- Last updated
- 2013-08-21
Locations
37 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01621399. Inclusion in this directory is not an endorsement.