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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02418845
Recruitment Status : Completed
First Posted : April 16, 2015
Last Update Posted : March 30, 2016
Information provided by (Responsible Party):
Symbiomix Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: SYM-1219 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Experimental: SYM-1219
Administered orally
Drug: SYM-1219
Placebo Comparator: Placebo
Administered orally
Drug: Placebo

Primary Outcome Measures :
  1. Clinical Outcome Responder Rate [ Time Frame: Study Days 21-30 ]
    Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20%

Secondary Outcome Measures :
  1. Nugent Score [ Time Frame: Study days 7-14 & study days 21-30 ]
    A score of 0-3 will be considered normal; a score of 4 and above will be considered abnormal

  2. Therapeutic Outcome Responder Rate [ Time Frame: Study days 7-14 & study days 21-30 ]
    A Therapeutic Outcome Responder is defined as a Clinical Outcome Responder with a normal Nugent Score (between 0-3)

  3. Composite measure of Adverse Events and changes in the patient's physical examination findings, vital signs, and clinical safety laboratory results [ Time Frame: Study Days 7-14 & study days 21-30 ]
  4. Investigator's clinical assessment [ Time Frame: Study days 7-14 & 21-30 ]
    Investigator's opinion of the need for additional BV treatment (Yes or No)

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02418845

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Sponsors and Collaborators
Symbiomix Therapeutics

Responsible Party: Symbiomix Therapeutics Identifier: NCT02418845     History of Changes
Other Study ID Numbers: SYM-1219-301
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: November 2015

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections