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A Phase 3, Single-Arm, Open-Label Study to Evaluate the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are 18 to 50 Years of Age and at Risk for Pregnancy

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Trial Profile

A Phase 3, Single-Arm, Open-Label Study to Evaluate the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are 18 to 50 Years of Age and at Risk for Pregnancy

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

Latest Information Update: 12 Mar 2024

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At a glance

  • Drugs Estradiol/norethisterone acetate/relugolix (Primary)
  • Indications Pregnancy
  • Focus Registrational; Therapeutic Use
  • Acronyms SERENE
  • Sponsors Myovant Sciences; Sumitomo Pharma; Sumitomo Pharma America
  • Most Recent Events

    • 05 Mar 2024 Planned End Date changed from 1 Apr 2025 to 1 Feb 2026.
    • 05 Mar 2024 Planned primary completion date changed from 1 Apr 2024 to 1 Feb 2025.
    • 24 Jan 2024 Status changed from recruiting to active, no longer recruiting.
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