A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis
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
1 other identifier
interventional
215
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2014
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 16, 2014
CompletedFirst Posted
Study publicly available on registry
May 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
December 14, 2017
CompletedNovember 13, 2020
October 1, 2020
5 months
May 16, 2014
November 16, 2017
October 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Cure of Bacterial Vaginosis
Study Days 21-30
Number of Patients With Therapeutic Cure
Study Days 21-30
Number of Patients With a Normal Nugent Score
Study Days 21-30
Study Arms (3)
SYM-1219 Low Dose
EXPERIMENTALAdministered orally
SYM-1219 High Dose
EXPERIMENTALAdministered orally
Placebo
PLACEBO COMPARATORAdministered orally
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Women's Health Care Research Corp.
San Diego, California, 92123, United States
Women's Medical Research Group, LLC
Clearwater, Florida, 33759, United States
Healthcare Clinical Data, Inc.
North Miami, Florida, 33161, United States
Atlanta North Gynecology, P.C
Roswell, Georgia, 30075, United States
Wayne State University
Detroit, Michigan, 48201, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, 48604, United States
Lawrence OB-GYN Clinical Research, LLC
Lawrenceville, New Jersey, 08648, United States
Scott Eder MD
Plainsboro, New Jersey, 08536, United States
Eastern Carolina Women's Center
New Bern, North Carolina, 28562, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114, United States
The Jackson Clinic, PA
Jackson, Tennessee, 38305, United States
TMC Life Research, Inc.
Houston, Texas, 77054, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Tidewater Physicians for Women
Virginia Beach, Virginia, 23502, United States
University of Washington, Harborview Medical Center
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 28697102DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP Clinical Operations
- Organization
- Symbiomix Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2014
First Posted
May 28, 2014
Study Start
May 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
November 13, 2020
Results First Posted
December 14, 2017
Record last verified: 2020-10