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

Bacterial Vaginosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418845
• Other study ID #: SYM-1219-301
• Status: Completed
• Phase: Phase 3
• 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
• 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)

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

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)