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LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

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Trial Profile

LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 May 2024

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At a glance

  • Drugs Estradiol/norethisterone acetate/relugolix (Primary)
  • Indications Uterine leiomyoma
  • Focus Registrational; Therapeutic Use
  • Acronyms LIBERTY EXTENSION
  • Sponsors Myovant Sciences
  • Most Recent Events

    • 18 Oct 2023 of secondary analysis assessing the efficacy and safety of relugolix combination therapy in the subgroup population of Black/African American women with uterine fibroids, published in the American Journal of Obstetrics and Gynecology
    • 09 Feb 2023 This trial has been discontinued in Poland.
    • 03 Nov 2022 Results of pooled analysis (NCT03049735; NCT03103087; NCT03412890) assessing the long-term efficacy and safety of relugolix combination therapy treatment for up to 52 weeks published in the Obstetrics and Gynecology
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