A Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 2 Grams for the Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis

Trial Profile

A Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 2 Grams for the Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Sep 2017

At a glance

  • Drugs Secnidazole (Primary)
  • Indications Bacterial vaginosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Symbiomix Therapeutics
  • Most Recent Events

    • 18 Sep 2017 According to a Symbiomix Therapeutics media release, the US FDA has approved Solosec (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women.
    • 06 Sep 2017 Results published in a Symbiomix Therapeutics Media Release.
    • 31 Aug 2017 Results assessing the safety and efficacy of the single-dose of oral secnidazole for the treatment of bacterial vaginosis, were published in the American Journal of Obstetrics and Gynecology
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