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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02418845
Other study ID # SYM-1219-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 28, 2015
Est. completion date December 5, 2015

Study information

Verified date September 2021
Source Symbiomix Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date December 5, 2015
Est. primary completion date October 5, 2015
Accepts healthy volunteers No
Gender Female
Age group 12 Years and older
Eligibility 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 Design


Intervention

Drug:
SYM-1219

Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Symbiomix Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
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