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: 28 Jul 2018

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).
    • 25 Jun 2012 Status changed from recruiting to active, no longer recruiting.
    • 04 Jun 2012 This trial has reached 60% its targeted enrolment, according to a Starpharma media release.
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