Safety and Efficacy Study to Treat Bacterial Vaginosis
|ClinicalTrials.gov Identifier: NCT01621399|
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : August 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Vaginosis||Drug: Product 55394 Drug: Placebo Vehicle (non-treatment)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||651 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||December 2012|
Placebo Comparator: Vehicle
Treatment with the vehicle (placebo)
Drug: Placebo Vehicle (non-treatment)
The vehicle vaginal gel in an applicator (placebo).
Experimental: Product 55394
Treatment with product 55394
Drug: Product 55394
Product 55394 vaginal gel in a prefilled applicator.
- Clinical Cure [ Time Frame: Day 21 ]The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator.
- Therapeutic Cure [ Time Frame: Day 21 ]The proportion of subjects with a therapeutic cure at the Day 21 visit. Therapeutic cure is defined as both a clinical cure and bacteriological cure as assessed by the investigator and the central laboratory, respectively.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621399
Show 37 Study Locations
|Study Director:||Ron Staugaard||Medicis Pharmaceutical|