Back to resultsA Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
Primary Purpose
Bacterial Vaginosis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SYM-1219
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SYM-1219
Placebo
Arm Description
Administered orally
Administered orally
Outcomes
Primary Outcome Measures
Clinical Outcome Responder Rate
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20%
Secondary Outcome Measures
Clinical Outcome Responder Rate (Interim Visit Only)
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20%
Gram Stain Slide Nugent Score
A score of 0-3 will be considered normal; a score of 4 and above will be considered abnormal
Therapeutic Outcome Responder Rate
A Therapeutic Outcome Responder is defined as a Clinical Outcome Responder with a normal Nugent Score (between 0-3)
Investigator's Clinical Assessment
Investigator's opinion of the need for additional Bacterial Vaginosis (BV) treatment (Yes or No)
Full Information
NCT ID
NCT02418845
First Posted
April 8, 2015
Last Updated
September 20, 2021
Sponsor
Symbiomix Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT02418845
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2015 (Actual)
Primary Completion Date
October 5, 2015 (Actual)
Study Completion Date
December 5, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Symbiomix Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SYM-1219
Arm Type
Experimental
Arm Description
Administered orally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
SYM-1219
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Clinical Outcome Responder Rate
Description
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20%
Time Frame
Study Days 21-30 (End of Study (EOS))
Secondary Outcome Measure Information:
Title
Clinical Outcome Responder Rate (Interim Visit Only)
Description
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20%
Time Frame
Study Days 7-14 (interim)
Title
Gram Stain Slide Nugent Score
Description
A score of 0-3 will be considered normal; a score of 4 and above will be considered abnormal
Time Frame
Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS)
Title
Therapeutic Outcome Responder Rate
Description
A Therapeutic Outcome Responder is defined as a Clinical Outcome Responder with a normal Nugent Score (between 0-3)
Time Frame
Study days 7-14 (interim) & study days 21-30 (EOS)
Title
Investigator's Clinical Assessment
Description
Investigator's opinion of the need for additional Bacterial Vaginosis (BV) treatment (Yes or No)
Time Frame
Study days 21-30 End of Study (EOS)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
73212
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
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