NCT01621399CompletedPhase 3
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
Medicis Global Service Corporation0 sites651 target enrollmentStarted: May 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 651
- Primary Endpoint
- Clinical Cure
Study Overview
Brief Summary
The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have a clinical diagnosis of bacterial vaginosis as determined by the investigator.
- •Other items as identified in the protocol.
Exclusion Criteria
- •Have a known or suspected other infectious cause of vulvovaginitis.
- •Other items as identified in the protocol.
Arms & Interventions
Vehicle
Placebo Comparator
Treatment with the vehicle (placebo)
Intervention: Placebo Vehicle (non-treatment) (Drug)
Product 55394
Experimental
Treatment with product 55394
Intervention: Product 55394 (Drug)
Outcomes
Primary Outcomes
Clinical Cure
Time Frame: Day 21
The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator.
Secondary Outcomes
- Therapeutic Cure(Day 21)
Investigators
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