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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VT-1161 Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VT-1161 Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis

Recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Jan 2019

At a glance

  • Drugs Oteseconazole (Primary)
  • Indications Vulvovaginal candidiasis
  • Focus Registrational; Therapeutic Use
  • Acronyms VIOLET
  • Sponsors Mycovia Pharmaceuticals
  • Most Recent Events

    • 06 Sep 2018 Status changed from not yet recruiting to recruiting according to the Mycovia Pharmaceuticals media release.
    • 06 Sep 2018 According to the Mycovia Pharmaceuticals media release, the company expects to complete VIOLET studies of the RVVC program in the second half of 2020 in anticipation of regulatory submissions in the United States, European Union and Japan. Following meetings with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, Mycovia has alignment with the regulatory agencies on the key aspects of the VIOLET trials.
    • 06 Sep 2018 According to Mycovia Pharmaceuticals media release, company announced the initiation of two Phase 3 clinical trials called VIOLET
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