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SPIRIT 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain

Trial Profile

SPIRIT 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Oct 2019

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At a glance

  • Drugs Estradiol/norethisterone (Primary) ; Relugolix (Primary)
  • Indications Endometriosis; Pelvic pain
  • Focus Registrational; Therapeutic Use
  • Acronyms SPIRIT 2
  • Sponsors Myovant Sciences
  • Most Recent Events

    • 21 Oct 2019 According to a Myovant Sciences media release, the Phase 3 clinical program for endometriosis consists of two multinational, replicate pivotal clinical studies (SPIRIT 1 and SPIRIT 2).These studies support potential regulatory submission for a single tablet, once-daily treatment of moderate-to-severe endometriosis-associated pain.
    • 10 Oct 2019 Status changed from recruiting to active, no longer recruiting.
    • 22 Aug 2019 Status changed from active, no longer recruiting to recruiting.
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