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

Trial Profile

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

Planning
Phase of Trial: Phase III

Latest Information Update: 31 Jan 2017

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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top