A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Symbiomix Therapeutics
• Treatments: Secnidazole

Criteria

Inclusion Criteria:

• Are females at least 18 years of age in good general health who are not menopausal.

• 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 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).