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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jul 2019

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At a glance

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

    • 27 Feb 2019 According to an Starpharma media release, US FDA completed review of the VivaGel NDA and advised it requires confirmatory clinical data prior to approval. In preparation for a meeting with the FDA to discuss the data required, the company has been working with FDA consultants and is currently awaiting confirmation of the meeting date.
    • 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.
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