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