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A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain.

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Trial Profile

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain.

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 31 Oct 2024

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At a glance

  • Drugs Linzagolix (Primary) ; Estradiol/norethisterone
  • Indications Endometriosis; Pelvic pain
  • Focus Registrational; Therapeutic Use
  • Acronyms EDELWEISS 2
  • Sponsors Kissei Pharmaceutical; ObsEva

Most Recent Events

  • 11 Jan 2021 Status changed from suspended to discontinued, according to an ObsEva media release.
  • 11 Jan 2021 According to an ObsEva media release, Screening and enrollment for this trial in the US has been increasingly challenging, particularly in the context of the persisting difficult environment of the ongoing pandemic and has led to ObsEva decision to discontinue the study.
  • 05 Nov 2020 According to an ObsEva media release, this trial has resumed the enrollment of new patients in the latter part of the second quarter, and enrollment continued during the third quarter.

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