A multi-center, open-label study to evaluate the treatment of one oral dose of 2g Solosec™ (Secnidazole) in adolescent girls with BV
This is a multi-center, open-label study to evaluate the safety of Solosec in adolescent girls with bacterial vaginosis. Approximately 40 patients will be enrolled. Patients determined to be eligible at the Baseline Visit (Day 1) will receive a single oral dose of Solosec™ granules (containing 2 grams of secnidazole) on Day 1. Patients will return to the site once between Days 7-14 for a "test of cure" (TOC) Visit. A follow-up telephone call will be performed at Days 21-30 to assess the continued clinical response to treatment and adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
One dose
Site 1004 - Investigational Research Center
Long Beach, California, United States
Site 1005 - Investigational Research Center
Hialeah, Florida, United States
Site 1001 - Investigational Research Center
Miami Lakes, Florida, United States
Clinical Outcome Responder
Defined as patients with resolution of abnormal vaginal , negative 10% KOF WHIFF test, and Clue cells less than 20% of the total epithelial cells
Time frame: At TOC visit study day 7-14
Nugent Score
All patients with a score of 0-3 will be considered normal; scores of 4 and above will considered abnormal.
Time frame: At TOC visit study day 7-14
Investigator Clinical Assessment
Investigator's opinion of the need for additional BV treatment. (Yes/No)
Time frame: At TOC visit study day 7-14
Patient's Continued Clinical Response
Investigator's opinion of the continued clinical response to treatment (Yes/No)
Time frame: At TOC visit study day 7-14
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Site 1010 - Investigational Research Center
Sarasota, Florida, United States
Site 1013
Tampa, Florida, United States
Site 1011 - Investigational Research Center
Bardstown, Kentucky, United States
Site 1008 - Investigational Research Center
Saginaw, Michigan, United States
Site 1007 - Investigational Research Center
Memphis, Tennessee, United States
Site 1006 - Investigational Research Center
Frisco, Texas, United States