Back to resultsSafety and Efficacy Study to Treat Bacterial Vaginosis
Primary Purpose
Bacterial Vaginosis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Product 55394
Placebo Vehicle (non-treatment)
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginosis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Vehicle
Product 55394
Arm Description
Treatment with the vehicle (placebo)
Treatment with product 55394
Outcomes
Primary Outcome Measures
Clinical Cure
The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator.
Secondary Outcome Measures
Therapeutic Cure
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.
Full Information
NCT ID
NCT01621399
First Posted
June 14, 2012
Last Updated
August 20, 2013
Sponsor
Medicis Global Service Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01621399
Brief Title
Safety and Efficacy Study to Treat Bacterial Vaginosis
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 Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medicis Global Service Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
651 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Treatment with the vehicle (placebo)
Arm Title
Product 55394
Arm Type
Experimental
Arm Description
Treatment with product 55394
Intervention Type
Drug
Intervention Name(s)
Product 55394
Intervention Description
Product 55394 vaginal gel in a prefilled applicator.
Intervention Type
Drug
Intervention Name(s)
Placebo Vehicle (non-treatment)
Intervention Description
The vehicle vaginal gel in an applicator (placebo).
Primary Outcome Measure Information:
Title
Clinical Cure
Description
The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator.
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
Therapeutic Cure
Description
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.
Time Frame
Day 21
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Staugaard
Organizational Affiliation
Medicis Pharmaceutical
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
La Mesa
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Groton
State/Province
Connecticut
Country
United States
City
Boyton Beach
State/Province
Florida
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
North Miami
State/Province
Florida
Country
United States
City
Sunrise
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Augusta
State/Province
Georgia
Country
United States
City
Roswell
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Marrero
State/Province
Louisiana
Country
United States
City
Falls River
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Saginaw
State/Province
Michigan
Country
United States
City
Lincoln
State/Province
Nebraska
Country
United States
City
Lawrenceville
State/Province
New Jersey
Country
United States
City
Neptune
State/Province
New Jersey
Country
United States
City
Plainsboro
State/Province
New Jersey
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Jenkintown
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Jackson
State/Province
Tennessee
Country
United States
City
Corpus Christi
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Schertz
State/Province
Texas
Country
United States
City
Williston
State/Province
Vermont
Country
United States
City
Virginia Beach
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Tacoma
State/Province
Washington
Country
United States
12. IPD Sharing Statement
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Safety and Efficacy Study to Treat Bacterial Vaginosis
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