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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Feb 2020

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At a glance

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

    • 21 Dec 2017 According to a Starpharma media release, the company has completed the VivaGel BV treatment clinical section of the NDA clinical module, which will be submitted to the FDA under Starpharma's rolling submission on Friday 22 December 2017. The BV treatment section data is based on this and another phase III trial (CT profile 204838).
    • 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.
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