A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
NCT ID: NCT02418845
Last Updated: 2021-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
189 participants
INTERVENTIONAL
2015-05-28
2015-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SYM-1219
Administered orally
SYM-1219
Placebo
Administered orally
Placebo
Interventions
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SYM-1219
Placebo
Eligibility Criteria
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Inclusion Criteria
* Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
* Off-white (milky or gray), thin, homogeneous vaginal discharge
* Vaginal pH ≥ 4.7
* Presence of Clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount
* A positive 10% KOH Whiff test
* Have a Gram stain slide Nugent Score ≥ 4 at the Baseline Visit (Day 1)
Exclusion Criteria
* Are menstruating or have vaginal bleeding at the Baseline Visit (Day 1)
* Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex
* Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline Visit (Day 1)
12 Years
FEMALE
No
Sponsors
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Symbiomix Therapeutics
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Jonesboro, Arkansas, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Leesburg, Florida, United States
Miami, Florida, United States
Wellington, Florida, United States
Atlanta, Georgia, United States
Baltimore, Maryland, United States
Grand Rapids, Michigan, United States
Plainsboro, New Jersey, United States
New Bern, North Carolina, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Myrtle Beach, South Carolina, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Virginia Beach, Virginia, United States
Seattle, Washington, United States
Countries
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Other Identifiers
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SYM-1219-301
Identifier Type: -
Identifier Source: org_study_id