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

Phase 3

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Drug: Placebo; Drug: SYM-1219

• Registration Number: NCT02418845
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Study Start: 2015-05-28
• Primary Completion: 2015-10-05
• Study Completion: 2015-12-05
• Disposition First Submitted: 2016-03-02
• Disposition First Submitted QC: 2016-03-02
• Disposition First Posted: 2016-03-30
• Results First Submitted: 2021-03-18
• Results First Submitted QC: 2021-03-18
• Results First Posted: 2021-04-13
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 189

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Administered orally
SYM-1219	SYM-1219	Administered orally

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical Outcome Responder Rate (Interim Visit Only)	Study Days 7-14 (interim)	Determined by Normal vaginal discharge, negative 10% KOH Whiff test, \& Clue cells less than 20%
Gram Stain Slide Nugent Score	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
Investigator's Clinical Assessment	Study days 21-30 End of Study (EOS)	Investigator's opinion of the need for additional Bacterial Vaginosis (BV) treatment (Yes or No)
Therapeutic Outcome Responder Rate	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)