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

Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jul 2018

At a glance

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

    • 09 Jul 2018 According to an Starpharma media release, US FDA has completed its filing review of the VivaGel BV New Drug Application (NDA), with no issues identified, and confirmed its progress to the next stage.
    • 30 Apr 2018 According to a Starpharma media release, rolling new drug application (NDA) for VivaGel BV including two indications, for the treatment and prevention of bacterial vaginosis (BV) , has been completed, and the final module of the NDA will be submitted to the US Food and Drug Administration (FDA) on Monday 30 April 2018.
    • 04 Dec 2017 Status changed from active, no longer recruiting to completed.
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