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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
189
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Jonesboro, Arkansas, United States
Clinical Outcome Responder Rate
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))
Clinical Outcome Responder Rate (Interim Visit Only)
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, \& Clue cells less than 20%
Time frame: Study Days 7-14 (interim)
Gram Stain Slide Nugent Score
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)
Therapeutic Outcome Responder Rate
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)
Investigator's Clinical Assessment
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
San Diego, California, United States
Unnamed facility
Colorado Springs, Colorado, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Leesburg, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Wellington, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Baltimore, Maryland, United States
...and 11 more locations