Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
NCT ID: NCT02237950
Last Updated: 2019-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
586 participants
INTERVENTIONAL
2014-10-13
2017-02-22
Brief Summary
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Detailed Description
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The primary endpoint will be determined at the conclusion of this 16 week treatment phase.
Participants who experience a BV recurrence will be considered to have completed the study. Such participants will receive BV treatment in line with local practice and will not attend any further study visits.
Participants who successfully reach Week 16 without a BV recurrence will enter a 12-week follow-up phase to Week 28.
Participants will attend a study visit at 4-weekly intervals throughout the duration of the study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse events.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1% SPL7013 Gel
Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Metronidazole oral tablets 500mg
One tablet taken orally twice daily for seven consecutive days
1% SPL7013 Gel
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
Placebo Gel
Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Metronidazole oral tablets 500mg
One tablet taken orally twice daily for seven consecutive days
Placebo gel
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
Interventions
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Metronidazole oral tablets 500mg
One tablet taken orally twice daily for seven consecutive days
1% SPL7013 Gel
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
Placebo gel
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of recurrent BV (at least 3 episodes in previous year including current episode)
* Using an effective method of contraception
Exclusion Criteria
* Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment
* Abnormal pelvic exam, including presence of other vaginal or urinary tract infections
* Pregnancy
16 Years
45 Years
FEMALE
No
Sponsors
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Starpharma Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Jeremy Paull, PhD.
Role: STUDY_CHAIR
Starpharma Pty Ltd
Locations
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University of Alabama
Birmingham, Alabama, United States
Montgomery Women's Health Associates
Montgomery, Alabama, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Precision Research Institute
San Diego, California, United States
Women's Health Care
San Diego, California, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Downtown Women's Health Care
Denver, Colorado, United States
The Community Research South Florida
Hialeah, Florida, United States
Florida Medical Center and Research Inc.
Miami, Florida, United States
Research Institute of South Florida
Miami, Florida, United States
Community Medical Research
Miami Beach, Florida, United States
Comprehensive Clinical Trials
West Palm Beach, Florida, United States
Atlanta Medical Research Institute
Alpharetta, Georgia, United States
Urban Family Practice Associates
Marietta, Georgia, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
Women's Healthcare Specialists
Paw Paw, Michigan, United States
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, United States
Alegent Creighton Health
Omaha, Nebraska, United States
Affiliated Clinical Research
Las Vegas, Nevada, United States
Lawrence OB-GYN Associates
Lawrenceville, New Jersey, United States
PMG Research of Cary, LLC
Cary, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
Radiant Research
Akron, Ohio, United States
Radiant Research
Columbus, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, United States
Clinical Research Advantage
Anderson, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Chattanooga Medical Research
Chattanooga, Tennessee, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Women's Physician Group
Memphis, Tennessee, United States
Practice Research Organization
Dallas, Texas, United States
Radiant Research
San Antonio, Texas, United States
Jordan River Family Medicine
South Jordan, Utah, United States
Clinical Trials of Virginia
Richmond, Virginia, United States
Women's Clinical Research Center
Seattle, Washington, United States
Medicine Professional Corporation
Kitchener, Ontario, Canada
SKDS Research Inc
Newmarket, Ontario, Canada
Healthy Image Centre
Windsor, Ontario, Canada
DIEX Recherche Montreal Inc
Montreal, Quebec, Canada
DIEX Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Torre Auxillo Mutuo
Hato Rey, , Puerto Rico
Latin Clinical Trial Center
San Juan, , Puerto Rico
University of Puerto Rico
San Juan, , Puerto Rico
Countries
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Other Identifiers
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SPL7013-017
Identifier Type: -
Identifier Source: org_study_id
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