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
1 other identifier
interventional
651
1 country
37
Brief Summary
The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2012
Shorter than P25 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 14, 2012
CompletedFirst Posted
Study publicly available on registry
June 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 21, 2013
August 1, 2013
5 months
June 14, 2012
August 20, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Cure
The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator.
Day 21
Secondary Outcomes (1)
Therapeutic Cure
Day 21
Study Arms (2)
Vehicle
PLACEBO COMPARATORTreatment with the vehicle (placebo)
Product 55394
EXPERIMENTALTreatment with product 55394
Interventions
Eligibility Criteria
You may qualify if:
- Have a clinical diagnosis of bacterial vaginosis as determined by the investigator.
- Other items as identified in the protocol.
You may not qualify if:
- Have a known or suspected other infectious cause of vulvovaginitis.
- Other items as identified in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
La Mesa, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Groton, Connecticut, United States
Unknown Facility
Boyton Beach, Florida, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
North Miami, Florida, United States
Unknown Facility
Sunrise, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Roswell, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Marrero, Louisiana, United States
Unknown Facility
Falls River, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Saginaw, Michigan, United States
Unknown Facility
Lincoln, Nebraska, United States
Unknown Facility
Lawrenceville, New Jersey, United States
Unknown Facility
Neptune City, New Jersey, United States
Unknown Facility
Plainsboro, New Jersey, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Jenkintown, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
Jackson, Tennessee, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Schertz, Texas, United States
Unknown Facility
Williston, Vermont, United States
Unknown Facility
Virginia Beach, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Tacoma, Washington, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ron Staugaard
Medicis Pharmaceutical
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2012
First Posted
June 18, 2012
Study Start
May 1, 2012
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
August 21, 2013
Record last verified: 2013-08