Clinical trial NCT02147899: A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bacterial Vaginosis
Lead sponsor: Symbiomix Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-05-28
Enrollment: 215
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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).

Primary outcomes:
measure: Cure of Bacterial Vaginosis
timeFrame: Study Days 21-30
Secondary outcomes:
measure: Cure of Bacterial Vaginosis
timeFrame: Study Days 21-30
measure: Number of Patients With Therapeutic Cure
timeFrame: Study Days 21-30
measure: Number of Patients With a Normal Nugent Score
timeFrame: Study Days 21-30
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: Women's Health Care Research Corp.
state: California
city: Clearwater
country: United States
facility: Women's Medical Research Group, LLC
state: Florida
city: North Miami
country: United States
facility: Healthcare Clinical Data, Inc.
state: Florida
city: Roswell
country: United States
facility: Atlanta North Gynecology, P.C
state: Georgia
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group, LLC
state: Michigan
city: Lawrenceville
country: United States
facility: Lawrence OB-GYN Clinical Research, LLC
state: New Jersey
city: Plainsboro
country: United States
facility: Scott Eder MD
state: New Jersey
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Jackson
country: United States
facility: The Jackson Clinic, PA
state: Tennessee
city: Houston
country: United States
facility: TMC Life Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Virginia Beach
country: United States
facility: Tidewater Physicians for Women
state: Virginia
city: Seattle
country: United States
facility: University of Washington, Harborview Medical Center
state: Washington
Study officials:
References:
citation: Hillier SL, Nyirjesy P, Waldbaum AS, Schwebke JR, Morgan FG, Adetoro NA, Braun CJ. Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial. Obstet Gynecol. 2017 Aug;130(2):379-386. doi: 10.1097/AOG.0000000000002135.