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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

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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: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Sep 2023

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At a glance

  • Drugs Estradiol/norethisterone acetate/relugolix (Primary) ; Relugolix (Primary)
  • Indications Dysmenorrhoea; Pelvic pain
  • Focus Registrational; Therapeutic Use
  • Acronyms SPIRIT 2
  • Sponsors Myovant Sciences

    • Most Recent Events

    • 15 Sep 2023 According to Sumitomo Pharma media release, the Committee for Medicinal Products for Human Use ("CHMP") of EMA has adopted a positive opinion recommending the approval of a Type II Variation application for RYEQO. The European Commission will review the CHMP recommendation and a final decision on the Marketing Authorization Application is expected to be available in the coming months. This application is supported by SPIRIT 1, SPIRIT 2 and 80-week, open-label extension studies.
    • 26 Oct 2022 Results assessing difference in treatment response to relugolix, estradiol, norethindrone acetate over 24 weeks between the overall and North American patients in SPIRIT-1 & SPIRIT-2 studies,presented at the 78th Scientific Congress of the American Society for Reproductive Medicine.
    • 05 Aug 2022 According to a Myovant Sciences media release, U.S. Food and Drug Administration (FDA) has approved MYFEMBREE(relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months. The approval is supported by one-year efficacy and safety data, including 24-week data from the Phase 3 SPIRIT 1 and SPIRIT 2 trials.
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