At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 147 enrolled
Drug / intervention
Secnidazole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-center, Prospective, Randomized, Placebo-Controlled, Delayed Treatment, Double-Blind Study to Evaluate the Effectiveness and Safety of a Single Oral Dose of Solosec® for the Treatment of Trichomoniasis
In Brief
A Phase 3 clinical trial evaluating Secnidazole and Placebo for Trichomonas Infection. Completed, enrolled 147 participants across 11 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrichomonas Infection
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartApr 2019
First PostedMay 2019
Primary CompletionMar 2020
Study CompletionMar 2020
TodayJul 2026
First PostedMay 2, 2019
Enrollment StartApr 23, 2019
Primary CompletionMar 2, 2020
Study CompletionMar 25, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.2 years ago
Interventions
Secnidazoledrug
Oral Granules containing secnidazole
Placebodrug
Oral Granules of placebo manufactured to mimic secnidazole