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

Trial Profile

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
  • Most Recent Events

    • 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.
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