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

October 19, 2020 updated by: Symbiomix Therapeutics

A Phase 2, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 for the Treatment of Women With Bacterial Vaginosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • San Diego, California, United States, 92123
        • Women's Health Care Research Corp.
    • Florida
      • Clearwater, Florida, United States, 33759
        • Women's Medical Research Group, LLC
      • North Miami, Florida, United States, 33161
        • Healthcare Clinical Data, Inc.
    • Georgia
      • Roswell, Georgia, United States, 30075
        • Atlanta North Gynecology, P.C
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Saginaw, Michigan, United States, 48604
        • Saginaw Valley Medical Research Group, LLC
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrence Ob-Gyn Clinical Research, LLC
      • Plainsboro, New Jersey, United States, 08536
        • Scott Eder MD
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Eastern Carolina Women's Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Clinical Research Of Philadelphia, Llc
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic, PA
    • Texas
      • Houston, Texas, United States, 77054
        • TMC Life Research, Inc.
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
    • Virginia
      • Virginia Beach, Virginia, United States, 23502
        • Tidewater Physicians for Women
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington, Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Administered orally
Drug: Placebo
Oral
Experimental: SYM-1219 Low Dose
Administered orally
Drug: SYM-1219
Oral
Other Names:
  • Secnidazole
Experimental: SYM-1219 High Dose
Administered orally
Drug: SYM-1219
Oral
Other Names:
  • Secnidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure of Bacterial Vaginosis
Time Frame: 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)
Study Days 21-30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure of Bacterial Vaginosis
Time Frame: 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)
Study Days 21-30
Number of Patients With Therapeutic Cure
Time Frame: 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.
Study Days 21-30
Number of Patients With a Normal Nugent Score
Time Frame: Study Days 21-30
The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.
Study Days 21-30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Symbiomix Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYM-1219-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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