A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
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
1 other identifier
interventional
189
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2015
Shorter than P25 for phase_3
21 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
First Submitted
Initial submission to the registry
April 8, 2015
CompletedFirst Posted
Study publicly available on registry
April 16, 2015
CompletedStudy Start
First participant enrolled
May 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2015
CompletedResults Posted
Study results publicly available
April 13, 2021
CompletedOctober 15, 2021
September 1, 2021
4 months
April 8, 2015
March 18, 2021
September 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Outcome Responder Rate
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, \& Clue cells less than 20%
Study Days 21-30 (End of Study (EOS))
Secondary Outcomes (4)
Clinical Outcome Responder Rate (Interim Visit Only)
Study Days 7-14 (interim)
Gram Stain Slide Nugent Score
Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS)
Therapeutic Outcome Responder Rate
Study days 7-14 (interim) & study days 21-30 (EOS)
Investigator's Clinical Assessment
Study days 21-30 End of Study (EOS)
Study Arms (2)
SYM-1219
EXPERIMENTALAdministered orally
Placebo
PLACEBO COMPARATORAdministered orally
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Jonesboro, Arkansas, 72401, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
Colorado Springs, Colorado, 80910, United States
Unknown Facility
Denver, Colorado, 80209, United States
Unknown Facility
Leesburg, Florida, 34748, United States
Unknown Facility
Miami, Florida, 33161, United States
Unknown Facility
Wellington, Florida, 33414, United States
Unknown Facility
Atlanta, Georgia, 30312, United States
Unknown Facility
Baltimore, Maryland, 21224, United States
Unknown Facility
Grand Rapids, Michigan, 49503, United States
Unknown Facility
Plainsboro, New Jersey, 08536, United States
Unknown Facility
New Bern, North Carolina, 28562, United States
Unknown Facility
Columbus, Ohio, 73212, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Philadelphia, Pennsylvania, 19114, United States
Unknown Facility
Myrtle Beach, South Carolina, 29572, United States
Unknown Facility
Corpus Christi, Texas, 78414, United States
Unknown Facility
Houston, Texas, 77054, United States
Unknown Facility
Virginia Beach, Virginia, 23456, United States
Unknown Facility
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gregory Kaufman, MD
- Organization
- Lupin Pharmaceuticals Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2015
First Posted
April 16, 2015
Study Start
May 28, 2015
Primary Completion
October 5, 2015
Study Completion
December 5, 2015
Last Updated
October 15, 2021
Results First Posted
April 13, 2021
Record last verified: 2021-09