Clinical trial NCT02418845: A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Vaginosis
Lead sponsor: Symbiomix Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-04-16
Enrollment: 189
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Clinical Outcome Responder Rate
timeFrame: Study Days 21-30 (End of Study (EOS))
Secondary outcomes:
measure: Clinical Outcome Responder Rate (Interim Visit Only)
timeFrame: Study Days 7-14 (interim)
measure: Gram Stain Slide Nugent Score
timeFrame: Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS)
measure: Therapeutic Outcome Responder Rate
timeFrame: Study days 7-14 (interim) & study days 21-30 (EOS)
measure: Investigator's Clinical Assessment
timeFrame: Study days 21-30 End of Study (EOS)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Jonesboro
country: United States
state: Arkansas
city: San Diego
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Leesburg
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Baltimore
country: United States
state: Maryland
city: Grand Rapids
country: United States
state: Michigan
city: Plainsboro
country: United States
state: New Jersey
city: New Bern
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Myrtle Beach
country: United States
state: South Carolina
city: Corpus Christi
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Virginia Beach
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
References: