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
  • Acronyms Harmony
  • Sponsors Starpharma
  • Most Recent Events

    • 07 Aug 2017 Results published in a Starpharma media release.
    • 07 Aug 2017 According to the 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 According to a Starpharma media release, primary endpoint (n=636) 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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