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A Phase 3 trial of Proellex® (telapristone acetate) for the treatment of symptomatic uterine fibroids

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A Phase 3 trial of Proellex® (telapristone acetate) for the treatment of symptomatic uterine fibroids

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 02 Feb 2017

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At a glance

  • Drugs Telapristone (Primary)
  • Indications Uterine leiomyoma
  • Focus Therapeutic Use

    • Most Recent Events

    • 31 Jan 2017 According to a Repros Therapeutics media release, the FDA has granted meeting to discuss the Phase 3 requirements to demonstrate both efficacy and safety for the development of Proellex for the treatment of uterine fibroids, the meeting is scheduled to occur before the end of April 2017.
    • 20 Dec 2016 New trial record
    • 12 Dec 2016 According to a Repros Therapeutics media release, company has requested a meeting with the FDA to discuss requirements for this trial and anticipates a meeting will be scheduled during the first half of 2017.

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