A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Assess the Efficacy and Safety of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

Trial Profile

A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Assess the Efficacy and Safety of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Sep 2015

At a glance

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

    • 24 Sep 2015 According to a Starpharma media release, marketing approval has been received for VivaGel BV for the treatment of bacterial vaginosis in the European Union.
    • 24 Oct 2012 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
    • 30 Jun 2012 Planned number of patients changed from 220 to 240 as reported by European Clinical Trials Database.
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