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A Randomized, Parallel-group, Double-blind Placebo-controlled and Open Label Active Controlled, Multi-center Study to Assess the Efficacy and Safety of Vilaprisan in Patients With Uterine Fibroids

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Trial Profile

A Randomized, Parallel-group, Double-blind Placebo-controlled and Open Label Active Controlled, Multi-center Study to Assess the Efficacy and Safety of Vilaprisan in Patients With Uterine Fibroids

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Apr 2022

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At a glance

  • Drugs Vilaprisan (Primary) ; Ulipristal
  • Indications Uterine leiomyoma
  • Focus Therapeutic Use
  • Acronyms ASTEROID 2
  • Sponsors Bayer; Bayer HealthCare

    • Most Recent Events

    • 30 Jul 2021 Results assessing exposure response modelling and simulation data of vilaprisan efficacy by using data from phase I and 2 studies including this study published in the British Journal of Clinical Pharmacology
    • 10 Oct 2018 Results of an integrated analysis of ASTEROID 1 and 2 studies aimed to assess the efficacy and safety of vilaprisan in women with uterine fibroids using an extended patient dataset, presented at the American Society for Reproductive Medicine Scientific Congress 2018
    • 10 Oct 2018 Results assessing efficacy and safety of Vilaprisan in women with uterine fibroid, presented at the American Society for Reproductive Medicine Scientific Congress 2018

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