drugset / Trial / NCT02236156

Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

NCT02236156

Phase 3 Completed 637 enrolled Starpharma Pty Ltd
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2014-10-03
Primary completion
2016-07-04
Completion
2016-10-04

Drugs

EvaluationDrugModalityDoseRoute
Subject SPL7013 Other / unclassified 5 g Other
Background Metronidazole Small molecule 500 mg Oral

Indications