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

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)