drugset / Trial / NCT02237950

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

NCT02237950

Phase 3 Completed 586 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
2014-10-13
Primary completion
2016-12-09
Completion
2017-02-22

Drugs

EvaluationDrugModalityDoseRoute
Subject SPL7013 Other / unclassified 1 % Other
Background Metronidazole Small molecule 500 mg Oral

Indications