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Multi-center, Prospective, Randomized, Placebo-Controlled, Delayed Treatment, Double-Blind Study to Evaluate the Effectiveness and Safety of a Single Oral Dose of Solosec for the Treatment of Trichomoniasis

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Trial Profile

Multi-center, Prospective, Randomized, Placebo-Controlled, Delayed Treatment, Double-Blind Study to Evaluate the Effectiveness and Safety of a Single Oral Dose of Solosec for the Treatment of Trichomoniasis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2023

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At a glance

  • Drugs Secnidazole (Primary)
  • Indications Trichomoniasis
  • Focus Registrational; Therapeutic Use
  • Sponsors Lupin

    • Most Recent Events

    • 01 Jul 2021 According to a Lupin Pharmaceuticals, Inc. media release, based on results from this trial company has received approval from the U.S. Food and Drug Administration (FDA) for the company's supplemental New Drug Application (sNDA) to expand the use of SOLOSEC (secnidazole) to include the treatment of trichomoniasis in adults.
    • 26 Mar 2021 Results published in the Clinical Infectious Diseases.
    • 16 Nov 2020 According to a Lupin Pharmaceuticals, Inc. media release, based on the results from this study, the U.S. Food and Drug Administration (FDA) has accepted their supplemental New Drug Application (sNDA) for Solosec (secnidazole) for the treatment of trichomoniasis in adults and adolescents. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of June 30, 2021.

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