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A Phase 3, Multicentre, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Daily Oral Administration of OBE2109 Alone and in Combination With Add-back Therapy for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

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A Phase 3, Multicentre, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Daily Oral Administration of OBE2109 Alone and in Combination With Add-back Therapy for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jun 2022

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At a glance

  • Drugs Linzagolix (Primary) ; Estradiol+norethisterone
  • Indications Uterine leiomyoma
  • Focus Registrational; Therapeutic Use
  • Acronyms PRIMROSE 2
  • Sponsors ObsEva

    • Most Recent Events

    • 17 Jun 2022 According to a Theramex media release, the EC decision follows confirmation of a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in April 2022, and is valid in all 27 European Union Member States, as well as Iceland, Norway, and Liechtenstein.
    • 17 Jun 2022 According to a Theramex media release, based on the results of PRIMROSE-1 and PRIMROSE-2 studies, the European Commission (EC) has granted marketing authorization for Yselty (linzagolix), an oral GnRH antagonist, for the management of moderate to severe symptoms of uterine fibroids (UF) in adult women (over 18 years of age) of reproductive age. This announcement is in partnership with ObsEva SA.
    • 17 Jun 2022 According to a Theramex media release, the European Commission (EC) has granted Marketing Authorization for Yselty (linzagolix) indicated for the treatment of moderate to severe symptoms of Uterine Fibroids in adult women of reproductive age. This announcement is in partnership with ObsEva SA.

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