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

Symbiomix Therapeutics

Status and phase

Completed

Phase 3

Conditions

Bacterial Vaginosis

Treatments

Drug: Placebo

Drug: SYM-1219

Study type

Interventional

Funder types

Industry

Identifiers

NCT02418845

SYM-1219-301

Details and patient eligibility

About

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.

Enrollment

189 patients

Sex

Female

Ages

12+ years old

Volunteers

No Healthy Volunteers

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)