deltatrials
Active Not Recruiting PHASE3 INTERVENTIONAL 1-arm NCT04756037

Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy (SERENE)

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

Sponsor: Sumitomo Pharma Switzerland GmbH

Conditions Contraception
Interventions Relugolix Combination Therapy
Updated 37 times since 2021 Last updated: Jan 6, 2026 Started: Mar 18, 2021 Primary completion: Feb 18, 2025 Completion: Feb 28, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04756037, this PHASE3 trial focuses on Contraception and remains ongoing. Sponsored by Sumitomo Pharma Switzerland GmbH, it has been updated 37 times since 2021, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Dec 2021 · 2 months · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Jan 2024 · 2 months · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jun 2025 · 9 months · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Feb 2026 – present · 4 months · monthly snapshot

Change History

37 versions recorded

  1. Feb 2026 — Present [monthly]

    Active Not Recruiting PHASE3

  2. Sep 2025 — Feb 2026 [monthly]

    Active Not Recruiting PHASE3

  3. Jun 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Sep 2024 — Jun 2025 [monthly]

    Active Not Recruiting PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

▶ Show 32 earlier versions

  1. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  2. Mar 2024 — Apr 2024 [monthly]

    Active Not Recruiting PHASE3

  3. Feb 2024 — Mar 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  4. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE3

  5. Nov 2023 — Jan 2024 [monthly]

    Recruiting PHASE3

  6. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE3

  7. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

  8. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  9. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE3

  10. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  11. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE3

  12. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE3

  13. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE3

  14. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE3

  15. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE3

  16. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  17. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  18. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  19. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  20. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  21. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  22. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  23. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  24. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE3

  25. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE3

  26. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  27. Oct 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

    Status: Suspended → Recruiting

  28. Sep 2021 — Oct 2021 [monthly]

    Suspended PHASE3

    Status: Recruiting → Suspended

  29. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  30. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  31. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  32. Mar 2021 — Apr 2021 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Sumitomo Pharma Switzerland GmbH
Data source: Sumitomo Pharma Switzerland GmbH

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albuquerque, United States , Annandale, United States , Atlanta, United States , Aurora, United States , Austin, United States , Aventura, United States , Baltimore, United States , Beaumont, United States , Bellevue, United States , Boynton Beach, United States and 83 more locations