This is a Phase 3, multi-center, prospective, randomized, placebo-controlled, delayed treatment, double-blind, study to evaluate the effectiveness, and safety of a single, oral dose of Solosec® containing 2 grams of secnidazole in female patients with trichomoniasis.
The study will consist of a primary study phase (Visit 1 (baseline) to Visit 2 (Day 6-12)) and a follow-up phase (Visit 2 to Visit 3 (7-12 days post Visit 2)). During the primary phase patients will be randomly assigned in a 1:1 ratio to either Solosec or placebo. Patients will return to the clinic for the "test of cure" (TOC) visit to be conducted on Days 6-12 (Visit 2). To ensure all patients receive treatment and to maintain the double-blind, after completion of the primary phase, patients will receive the opposite treatment , (placebo patients will receive Solosec and vice versa). Patients with V2 cultures that are subsequently positive for T. vaginalis will return to the clinic for Visit 3 (V3) assessments and investigator assessment of need for additional therapy (an additional Visit 4 may be scheduled at the investigator's discretion if culture at V3 is positive). Summary of results includes data reported during the primary phase of the study \[Visit 1 (baseline) to Visit 2/TOC (Day 6-12)\]
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
147
Oral Granules containing secnidazole
Oral Granules of placebo manufactured to mimic secnidazole
Site 1007
Birmingham, Alabama, United States
Site 1003
North Miami, Florida, United States
Site 1014
Chicago, Illinois, United States
Site 1013
Microbiological Cure at the TOC Visit
Vaginal Culture negative for T. vaginalis at TOC Visit
Time frame: Study Day 6-12
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Jackson, Mississippi, United States
Site 1009
Lawrenceville, New Jersey, United States
Site 1008
Chapel Hill, North Carolina, United States
Site 1004
Fayetteville, North Carolina, United States
Site 1011
Charleston, South Carolina, United States
Site 1001
Memphis, Tennessee, United States
Site 1002
Memphis, Tennessee, United States
...and 1 more locations