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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2022

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At a glance

  • Drugs Oteseconazole (Primary) ; Fluconazole
  • Indications Vulvovaginal candidiasis
  • Focus Registrational; Therapeutic Use
  • Acronyms ultraVIOLET
  • Sponsors Mycovia Pharmaceuticals

Most Recent Events

  • 25 Aug 2022 Results presented in the Mycovia Pharmaceuticals Media Release.
  • 18 Jul 2022 Results published in the American Journal of Obstetrics and Gynecology
  • 28 Apr 2022 According to a Mycovia Pharmaceuticals media release, U.S. Food and Drug Administration (FDA) approved VIVJOA (oteseconazole capsules), an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. VIVJOA's FDA approval is based upon the positive results from two global, pivotal VIOLET studies and one U.S.-focused ultraVIOLET study.

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