A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:12 - Any
Updated:4/21/2016
Start Date:May 2015
End Date:December 2015

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A Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 2 Grams for the Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis

The purpose of this clinical trial is to test the safety and efficacy of the oral
investigational new drug, SYM-1219 for the treatment of bacterial vaginosis.


Inclusion Criteria:

- Are premenopausal adult females or post menarchal adolescent girls ≥12 years of age
in good general health

- 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 pregnant, lactating, or planning to become pregnant during the study

- 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)
We found this trial at
21
sites
Myrtle Beach, South Carolina 29572
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Atlanta, GA
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Birmingham, AL
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Colorado Springs, Colorado 80910
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Columbus, OH
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Corpus Christi, TX
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Denver, CO
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Grand Rapids, MI
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Houston, TX
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Jonesboro, AR
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Leesburg, FL
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Miami, FL
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New Bern, NC
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Philadelphia, PA
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Philadelphia, PA
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Plainsboro, NJ
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San Diego, CA
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Seattle, WA
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Virginia Beach, VA
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Wellington, FL
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