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LIBERTY 2: 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 2: 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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2019

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At a glance

  • Drugs Relugolix (Primary) ; Estradiol/norethisterone
  • Indications Uterine leiomyoma
  • Focus Therapeutic Use
  • Acronyms LIBERTY 2
  • Sponsors Myovant Sciences
  • Most Recent Events

    • 12 Nov 2019 According to a Myovant Sciences media release, compoany plans to use the PRV in conjunction with its NDA submission for a once-daily, relugolix combination tablet for the treatment of heavy menstrual bleeding and uterine fibroids, Myovant has decided to defer its NDA submission for a once-daily, relugolix combination tablet for the treatment of heavy menstrual bleeding and uterine fibroids until April 2020, which would allow inclusion data of LIBERTY extension study.
    • 10 Oct 2019 Results presented in a Myovant Sciences Media Release.
    • 10 Oct 2019 According to a Myovant Sciences media release, results from LIBERTY 1 & 2 studies will be presented in the late-breaking oral session at the 2019 American Society for Reproductive Medicine (ASRM) Scientific Congress, which is being held October 12-16 in Philadelphia, Pennsylvania.
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