Overview

This trial is active, not recruiting.

Condition bacterial vaginosis
Treatments sym-1219, placebo
Phase phase 3
Sponsor Symbiomix Therapeutics
Start date May 2015
End date October 2015
Trial size 180 participants
Trial identifier NCT02418845, SYM-1219-301

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Administered orally
sym-1219
(Placebo Comparator)
Administered orally
placebo

Primary Outcomes

Measure
Clinical Outcome Responder Rate
time frame: Study Days 21-30

Secondary Outcomes

Measure
Nugent Score
time frame: Study days 7-14 & study days 21-30
Therapeutic Outcome Responder Rate
time frame: Study days 7-14 & study days 21-30
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
Investigator's clinical assessment
time frame: Study days 7-14 & 21-30

Eligibility Criteria

Female participants at least 12 years old.

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)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Symbiomix Therapeutics.