Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top