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

Completed · Phase 2 · Has a placebo group

Conditions studied: Bacterial Vaginosis

In brief

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.

Key facts

Study ID

NCT02147899

Run by

Symbiomix Therapeutics

People needed

215

Starts

2014-05-01

Expected to finish

2014-10-01

Last updated by the study team

2020-11-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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).

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Women's Health Care Research Corp. — San Diego, California, United States
• Women's Medical Research Group, LLC — Clearwater, Florida, United States
• Healthcare Clinical Data, Inc. — North Miami, Florida, United States
• Atlanta North Gynecology, P.C — Roswell, Georgia, United States
• Wayne State University — Detroit, Michigan, United States
• Saginaw Valley Medical Research Group, LLC — Saginaw, Michigan, United States
• Lawrence OB-GYN Clinical Research, LLC — Lawrenceville, New Jersey, United States
• Scott Eder MD — Plainsboro, New Jersey, United States
• Eastern Carolina Women's Center — New Bern, North Carolina, United States
• Clinical Research of Philadelphia, LLC — Philadelphia, Pennsylvania, United States
• The Jackson Clinic, PA — Jackson, Tennessee, United States
• TMC Life Research, Inc. — Houston, Texas, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
• Tidewater Physicians for Women — Virginia Beach, Virginia, United States
• University of Washington, Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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