NCT02418845CompletedPhase 3
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
Symbiomix Therapeutics0 sites189 target enrollmentStarted: May 28, 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 189
- Primary Endpoint
- Clinical Outcome Responder Rate
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
SYM-1219
Experimental
Administered orally
Intervention: SYM-1219 (Drug)
Placebo
Placebo Comparator
Administered orally
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Clinical Outcome Responder Rate
Time Frame: Study Days 21-30 (End of Study (EOS))
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, \& Clue cells less than 20%
Secondary Outcomes
- Clinical Outcome Responder Rate (Interim Visit Only)(Study Days 7-14 (interim))
- Gram Stain Slide Nugent Score(Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS))
- Investigator's Clinical Assessment(Study days 21-30 End of Study (EOS))
- Therapeutic Outcome Responder Rate(Study days 7-14 (interim) & study days 21-30 (EOS))
Investigators
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