CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 586 enrolled
Drug / intervention
Metronidazole oral tablets 500mg +2 moredrug
Likely dose
Metronidazole oral tablets 500mgfrom 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.

Search/NCT02237950
NCT02237950Phase 3Completed
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A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Determine the Efficacy and Safety of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis

Starpharma Pty Ltd·interventional·Posted Sep 12, 2014·Updated Jul 22, 2019

In Brief

A Phase 3 clinical trial evaluating Metronidazole oral tablets 500mg, 1% SPL7013 Gel, and 1 other intervention for Bacterial Vaginosis. Completed, enrolled 586 participants across 45 sites in 3 countries.

Detailed Summary

A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Vaginosis
CountriesCanada, Puerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 12, 2014
Enrollment StartOct 13, 2014
Primary CompletionDec 9, 2016
Study CompletionFeb 22, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.8 years ago

Interventions

Metronidazole oral tablets 500mgdrug

One tablet taken orally twice daily for seven consecutive days

1% SPL7013 Geldrug

5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.

Placebo geldrug

5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks