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LIBERTY 1: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy & Safety Study of Relugolix Co-Administered With/Without Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Trial Profile

LIBERTY 1: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy & Safety Study of Relugolix Co-Administered With/Without Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Nov 2018

At a glance

  • Drugs Relugolix (Primary) ; Estradiol/norethisterone
  • Indications Uterine leiomyoma
  • Focus Therapeutic Use
  • Acronyms LIBERTY 1
  • Sponsors Myovant Sciences
  • Most Recent Events

    • 17 Nov 2018 Planned End Date changed from 1 Jun 2019 to 30 Dec 2019.
    • 17 Nov 2018 Planned primary completion date changed from 1 Dec 2018 to 30 Jun 2019.
    • 08 Nov 2018 According to a Myovant Sciences media release, a New Drug Application (NDA) filing expected in the fourth quarter of 2019.
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