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LIBERTY 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

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Trial Profile

LIBERTY 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered With and Without 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: 18 Sep 2023

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At a glance

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

    • 17 Aug 2023 Results of post-hoc subgroup analysis assessing the safety and efficacy of relugolix-combination therapy in European women from pivotal trials (LIBERTY 1 and LIBERTY 2) published in the Gynecological Endocrinology.
    • 09 Nov 2022 Results of a pooled analysis from two clinical studies (LIBERTY 1 and LIBERTY 2) assessing effect of relugolix combination therapy on symptom burden and health-related quality of life in women with uterine fibroids published in the American Journal of Obstetrics and Gynecology
    • 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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