At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 325 enrolled
Drug / intervention
SYM-1219drug
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, Open-Label Study to Evaluate the Safety of A Single Dose of SYM-1219, a Granule Formulation Containing 2 Grams of Secnidazole, for the Treatment of Women and Postmenarchal Adolescent Girls With Bacterial Vaginosis
In Brief
A Phase 3 clinical trial evaluating SYM-1219 for Bacterial Vaginosis. Completed, enrolled 325 participants across 40 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Vaginosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartJun 2015
Primary CompletionOct 2015
TodayJul 2026
First PostedMay 25, 2015
Enrollment StartJun 1, 2015
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.1 years ago
Interventions
SYM-1219drug
Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water