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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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Dec 2018

At a glance

  • Drugs Linzagolix (Primary)
  • Indications Uterine leiomyoma
  • Focus Therapeutic Use
  • Acronyms PRIMROSE 1
  • Sponsors ObsEva
  • Most Recent Events

    • 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.
    • 16 May 2018 According to an ObsEva media release, enrolment completion in this trial is anticipated in Q1:2019.
    • 14 Nov 2017 According to an ObsEva media release, the company expects to complete patient enrollment in late 2018.
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