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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Drug: SYM-1219
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYM-1219<br>Administered orally | Drug: SYM-1219<br> <br> |
| Placebo Comparator: Placebo<br>Administered orally | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome Responder Rate | Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20% | Study Days 21-30 (End of Study (EOS)) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome Responder Rate (Interim Visit Only) | Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20% | Study Days 7-14 (interim) | 
| Gram Stain Slide Nugent Score | A score of 0-3 will be considered normal; a score of 4 and above will be considered abnormal | Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS) | 
| Therapeutic Outcome Responder Rate | A Therapeutic Outcome Responder is defined as a Clinical Outcome Responder with a normal Nugent Score (between 0-3) | Study days 7-14 (interim) & study days 21-30 (EOS) | 
| Investigator's Clinical Assessment | Investigator's opinion of the need for additional Bacterial Vaginosis (BV) treatment (Yes or No) | Study days 21-30 End of Study (EOS) |