At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 132 enrolled
Drug / intervention
0.5% SPL7013 Gel +3 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.
A Double-blind, Multi-center, Randomized, Placebo Controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally in the Treatment of Bacterial Vaginosis
In Brief
A Phase 2 clinical trial evaluating 0.5% SPL7013 Gel, 1.0% SPL7013 Gel, and 2 other interventions for Bacterial Vaginosis. Completed, enrolled 132 participants across 5 sites.
Detailed Summary
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Vaginosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
First PostedSep 2010
Primary CompletionMar 2011
Study CompletionMay 2011
TodayJul 2026
First PostedSep 14, 2010
Enrollment StartAug 1, 2010
Primary CompletionMar 1, 2011
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.8 years ago
Interventions
0.5% SPL7013 Geldrug
Vaginal gel
1.0% SPL7013 Geldrug
Vaginal gel
3.0% SPL7013 Geldrug
Vaginal gel
Placebo Gelother
Vaginal gel