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

Phase 2

Completed

Brief 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.

Detailed Description: :This was a Phase 2, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectivenessand safety of SYM-1219 in women with bacterial vaginosis. Patients determined to be eligible for the study were randomized to one of the following treatments: SYM-1219 1 gram orallyas a single dose;SYM-1219 2 grams orally as a single dose;or matching placebo. Patients determined to be eligible based on the clinical assessments at the Baseline visit (Day 1) were randomized in a 1:1:1 ratio and received a singledose of the assigned study treatment on Day 1 under fasted conditions (i.e., no food 2 hours prior to or 1 hour after dosing). The centralized randomization was stratified by the number of reported episodes of BV in the past 12 months (including the current episode): 3 or fewer episodes versus 4 or more episodes. Patients were asked to complete a daily telephone questionnaire on Days1to7 and at the Test of Cure (TOC)/End of Study (EOS)visit. Patients were also contacted by telephone once on Day 8 to 10 to inquire about possible adverse events (AEs). A TOC visit was conducted between Day 21 and 30; or at EOSif the final visit was notconducted between Day 21and30

Recruitment & Eligibility

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).

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Cure of Bacterial Vaginosis	Study Days 21-30	Clinical Cure is a composite endpoint determined by normalization of the vaginal discharge and a negative KOH "Whiff" test and Clue cells less than 20% of the total epithelial cells on microscopic examination of the vaginal wet mount. (Number of subjects with clinical cure at TOC/EOS)

Secondary Outcome Measures

Name	Time	Method
Cure of Bacterial Vaginosis	Study Days 21-30	Number of subjects with therapeutic cure at Test of Cure (TOC)/End of Study (EOS) (clinical cure + normalization of Nugent score)
Number of Patients With Therapeutic Cure	Study Days 21-30	Clinical Cure and Normalization of the Nugent score. The Nugent score is based on a microscopic assessment of a Gram stain of the vaginal fluid.
Number of Patients With a Normal Nugent Score	Study Days 21-30	The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.

Locations (16): Women's Medical Research Group, LLC
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Clearwater, Florida, United States
Tidewater Physicians for Women
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Virginia Beach, Virginia, United States
Clinical Research of Philadelphia, LLC
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Philadelphia, Pennsylvania, United States
TMC Life Research, Inc.
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Houston, Texas, United States
University of Washington, Harborview Medical Center
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Seattle, Washington, United States
The Jackson Clinic, PA
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Jackson, Tennessee, United States
Lawrence OB-GYN Clinical Research, LLC
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Lawrenceville, New Jersey, United States
Saginaw Valley Medical Research Group, LLC
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Saginaw, Michigan, United States
Scott Eder MD
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Plainsboro, New Jersey, United States
Clinical Trials of Texas, Inc.
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San Antonio, Texas, United States
University of Alabama at Birmingham
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Birmingham, Alabama, United States
Women's Health Care Research Corp.
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San Diego, California, United States
Wayne State University
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Detroit, Michigan, United States
Healthcare Clinical Data, Inc.
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North Miami, Florida, United States
Atlanta North Gynecology, P.C
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Roswell, Georgia, United States
Eastern Carolina Women's Center
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New Bern, North Carolina, United States