This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.
Approximately 325 patients will be enrolled. Patients determined to be eligible for the study will receive SYM-1219 granules containing 2 grams of secnidazole orally as a single dose. Patients determined to be eligible at the Baseline visit will receive a single dose of SYM-1219 granules containing 2 grams of secnidazole in 4 ounces of unsweetened applesauce to be self-administered on Day 1. Patients will be contacted by telephone once between Days 8 to 10 to inquire about possible adverse events. A final study visit will occur on Day 21 to 30 to assess the patient for safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
325
Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water
Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities
Safety evaluations will be based on the incidence, intensity, and type of AEs of subjects with clinical cure at TOC/EOS (clinical cure basd on amsel + normalization of Nugent score)
Time frame: 30days
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Jonesboro, Arkansas, United States
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La Mesa, California, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Groton, Connecticut, United States
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Clearwater, Florida, United States
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Leesburg, Florida, United States
...and 30 more locations