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

A Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 2 Grams for the Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Drug: Placebo; Drug: SYM-1219

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
  • California
    • San Diego, California, United States, 92108
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
    • Denver, Colorado, United States, 80209
  • Florida
    • Leesburg, Florida, United States, 34748
    • Miami, Florida, United States, 33161
    • Wellington, Florida, United States, 33414
  • Georgia
    • Atlanta, Georgia, United States, 30312
  • Maryland
    • Baltimore, Maryland, United States, 21224
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
  • New Jersey
    • Plainsboro, New Jersey, United States, 08536
  • North Carolina
    • New Bern, North Carolina, United States, 28562
  • Ohio
    • Columbus, Ohio, United States, 73212
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
    • Philadelphia, Pennsylvania, United States, 19114
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
  • Texas
    • Corpus Christi, Texas, United States, 78414
    • Houston, Texas, United States, 77054
  • Virginia
    • Virginia Beach, Virginia, United States, 23456
  • Washington
    • Seattle, Washington, United States, 98105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYM-1219; Administered orally	Drug: SYM-1219
Placebo Comparator: Placebo; Administered orally	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome Responder Rate	Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20%	Study Days 21-30 (End of Study (EOS))

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome Responder Rate (Interim Visit Only)	Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20%	Study Days 7-14 (interim)
Gram Stain Slide Nugent Score	A score of 0-3 will be considered normal; a score of 4 and above will be considered abnormal	Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS)
Therapeutic Outcome Responder Rate	A Therapeutic Outcome Responder is defined as a Clinical Outcome Responder with a normal Nugent Score (between 0-3)	Study days 7-14 (interim) & study days 21-30 (EOS)
Investigator's Clinical Assessment	Investigator's opinion of the need for additional Bacterial Vaginosis (BV) treatment (Yes or No)	Study days 21-30 End of Study (EOS)

Collaborators and Investigators

• Sponsor: Symbiomix Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2015
• Primary Completion (Actual): October 5, 2015
• Study Completion (Actual): December 5, 2015

Study Registration Dates

• First Submitted: April 8, 2015
• First Submitted That Met QC Criteria: April 15, 2015
• First Posted (Estimate): April 16, 2015

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial
• Other Study ID Numbers: SYM-1219-301