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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

Trial Profile

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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Dec 2018

At a glance

  • Drugs Linzagolix (Primary) ; Estradiol; Norethisterone
  • Indications Uterine leiomyoma
  • Focus Registrational; Therapeutic Use
  • Acronyms PRIMROSE 2
  • Sponsors ObsEva
  • Most Recent Events

    • 21 Dec 2018 According to an ObsEva media release, the company anticipate the primary endpoint read out of PRIMROSE 2 in Q4 2019.
    • 21 Dec 2018 Status changed from recruiting to active, no longer recruiting, according to an ObsEva media release.
    • 07 Dec 2018 According to an ObsEva media release, six-month primary endpoint results from this study is expected in the second half of 2019.
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