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Completed

NCT Number: NCT02418845

A Phase 3 Study of SYM-1219 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.

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

12 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SYM-1219

Drug

Placebo

Drug

Primary outcomes

  1. Clinical Outcome Responder Rate

    Time frame: Study Days 21-30 (End of Study (EOS))

    Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20%

Secondary outcomes

  1. Clinical Outcome Responder Rate (Interim Visit Only)

    Time frame: Study Days 7-14 (interim)

    Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20%

  2. Gram Stain Slide Nugent Score

    Time frame: Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS)

    A score of 0-3 will be considered normal; a score of 4 and above will be considered abnormal

  3. Therapeutic Outcome Responder Rate

    Time frame: Study days 7-14 (interim) & study days 21-30 (EOS)

    A Therapeutic Outcome Responder is defined as a Clinical Outcome Responder with a normal Nugent Score (between 0-3)

  4. Investigator's Clinical Assessment

    Time frame: Study days 21-30 End of Study (EOS)

    Investigator's opinion of the need for additional Bacterial Vaginosis (BV) treatment (Yes or No)

Sponsors and collaborators

Lead sponsor

Symbiomix Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 16, 2015
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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