deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT04003389

A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause (Skylight 4)

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause

Sponsor: Astellas Pharma Global Development, Inc.

Conditions Hot Flashes
Interventions fezolinetant placebo
Updated 33 times since 2019 Last updated: Oct 23, 2024 Started: Jul 10, 2019 Primary completion: Jan 4, 2022 Completion: Jan 4, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Hot Flashes and is currently completed. Astellas Pharma Global Development, Inc. leads this study, which shows 33 recorded versions since 2019 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Aug 2020 · 2 months · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~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 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Feb 2022 · 2 months · monthly snapshot~Feb 2022 – ~Mar 2023 · 13 months · monthly snapshot~Mar 2023 – ~Oct 2023 · 7 months · monthly snapshot~Oct 2023 – ~Jul 2024 · 9 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Sep 2025 · 9 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

33 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Dec 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Dec 2024 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Oct 2023 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 28 earlier versions

  1. Mar 2023 — Oct 2023 [monthly]

    Completed PHASE3

  2. Feb 2022 — Mar 2023 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Dec 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE3

  4. Nov 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE3

  5. Oct 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE3

  6. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE3

  7. Jun 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  8. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  9. Apr 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  10. Mar 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE3

  11. Feb 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE3

  12. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  13. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  14. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE3

  15. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE3

  16. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

  17. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE3

    Status: Active Not Recruiting → Recruiting

  18. Jun 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  19. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE3

  20. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

  21. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  22. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  23. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  24. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  25. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  26. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  27. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  28. Aug 2019 — Sep 2019 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Jul 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Astellas Pharma Global Development, Inc.
Data source: Astellas Pharma Inc

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

Study Locations

Albuquerque, United States , Andalusia, United States , Atlanta, United States , Austin, United States , Baltimore, United States , Beaumont, United States , Berlin, United States , Bialystok, Poland , Birmingham, United States , Brampton, Canada and 134 more locations