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
Phase of Trial: Phase III
Latest Information Update: 24 Sep 2015
At a glance
- Drugs Astodrimer (Primary)
- Indications Bacterial infections; Bacterial vaginosis
- Focus Registrational; Therapeutic Use
- Sponsors Starpharma
- 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.
- 30 Jun 2012 Planned number of patients changed from 220 to 240 as reported by European Clinical Trials Database.