A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis

Bacterial Vaginosis Clinical Trial

Official title:

A Phase 2, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 for the Treatment of Women With Bacterial Vaginosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147899
• Other study ID #: SYM-1219-201
• Status: Completed
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2020
• Source: Symbiomix Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.

Description:

:This was a Phase 2, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectivenessand safety of SYM-1219 in women with bacterial vaginosis. Patients determined to be eligible for the study were randomized to one of the following treatments: SYM-1219 1 gram orallyas a single dose;SYM-1219 2 grams orally as a single dose;or matching placebo. Patients determined to be eligible based on the clinical assessments at the Baseline visit (Day 1) were randomized in a 1:1:1 ratio and received a singledose of the assigned study treatment on Day 1 under fasted conditions (i.e., no food 2 hours prior to or 1 hour after dosing). The centralized randomization was stratified by the number of reported episodes of BV in the past 12 months (including the current episode): 3 or fewer episodes versus 4 or more episodes. Patients were asked to complete a daily telephone questionnaire on Days1to7 and at the Test of Cure (TOC)/End of Study (EOS)visit. Patients were also contacted by telephone once on Day 8 to 10 to inquire about possible adverse events (AEs). A TOC visit was conducted between Day 21 and 30; or at EOSif the final visit was notconducted between Day 21and30

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Are females at least 18 years of age in good general health who are not menopausal.
• 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 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
Oral
• Placebo
Oral

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Women's Medical Research Group, LLC	Clearwater	Florida
United States	Wayne State University	Detroit	Michigan
United States	TMC Life Research, Inc.	Houston	Texas
United States	The Jackson Clinic, PA	Jackson	Tennessee
United States	Lawrence OB-GYN Clinical Research, LLC	Lawrenceville	New Jersey
United States	Eastern Carolina Women's Center	New Bern	North Carolina
United States	Healthcare Clinical Data, Inc.	North Miami	Florida
United States	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Scott Eder MD	Plainsboro	New Jersey
United States	Atlanta North Gynecology, P.C	Roswell	Georgia
United States	Saginaw Valley Medical Research Group, LLC	Saginaw	Michigan
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Women's Health Care Research Corp.	San Diego	California
United States	University of Washington, Harborview Medical Center	Seattle	Washington
United States	Tidewater Physicians for Women	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Symbiomix Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure of Bacterial Vaginosis	Clinical Cure is a composite endpoint determined by normalization of the vaginal discharge and a negative KOH "Whiff" test and Clue cells less than 20% of the total epithelial cells on microscopic examination of the vaginal wet mount. (Number of subjects with clinical cure at TOC/EOS)	Study Days 21-30
Secondary	Cure of Bacterial Vaginosis	Number of subjects with therapeutic cure at Test of Cure (TOC)/End of Study (EOS) (clinical cure + normalization of Nugent score)	Study Days 21-30
Secondary	Number of Patients With Therapeutic Cure	Clinical Cure and Normalization of the Nugent score. The Nugent score is based on a microscopic assessment of a Gram stain of the vaginal fluid.	Study Days 21-30
Secondary	Number of Patients With a Normal Nugent Score	The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.	Study Days 21-30