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SPIRIT EXTENSION: An International Phase 3 Open-Label, Single-Arm, Safety and Efficacy Extension Study to Evaluate Relugolix Co-Administered with Low-Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain

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Trial Profile

SPIRIT EXTENSION: An International Phase 3 Open-Label, Single-Arm, Safety and Efficacy Extension Study to Evaluate Relugolix Co-Administered with Low-Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jul 2024

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At a glance

Most Recent Events

  • 01 Mar 2024 Results (n=681 at 52 weeks and n=501 at 104 weeks) assessing safety and efficacy of Relugolix CT, published in the Human Reproduction.
  • 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 and SPIRIT 2 and 80-week, open-label extension studies.
  • 27 Jun 2023 Status changed from active, no longer recruiting to completed.

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