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
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 21 Nov 2017
At a glance
- Drugs Astodrimer (Primary)
- Indications Bacterial vaginosis
- Focus Registrational; Therapeutic Use
- Sponsors Starpharma
- 21 Nov 2017 According to a Starpharma media release, US New Drug Application (NDA) submission for VivaGel BV for both treatment and prevention of BV has been lodged with the FDA through a rolling submission process.
- 25 Oct 2017 According to a Starpharma media release, the company has received Australian marketing approval from the Therapeutic Goods Administration (TGA) for VivaGel BV, which is intended for treatment of bacterial vaginosis (BV).
- 07 Aug 2017 According to a Starpharma media release, data from this trial will support marketing applications in the US, Europe and other countries for VivaGel for prevention of recurrent bacterial vaginosis.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History