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: 07 Aug 2017

At a glance

  • Drugs Astodrimer (Primary)
  • Indications Bacterial vaginosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Starpharma
  • Most Recent Events

    • 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.
    • 07 Aug 2017 Results published in a Starpharma media release.
    • 07 Aug 2017 According to a Starpharma media release, primary endpoint (n=585) has been met. (Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings)
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