deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02925494

An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Sponsor: AbbVie

Conditions Heavy Menstrual Bleeding Uterine Fibroids
Interventions Elagolix Estradiol/Norethindrone Acetate
Updated 21 times since 2017 Last updated: Jul 9, 2021 Started: Sep 14, 2016 Primary completion: May 7, 2018 Completion: Mar 22, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02925494, this PHASE3 trial focuses on Heavy Menstrual Bleeding and Uterine Fibroids and remains completed. Sponsored by AbbVie, it has been updated 21 times since 2016, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~May 2017 · 2 months · monthly snapshot~May 2017 – ~Aug 2017 · 3 months · monthly snapshot~Aug 2017 – ~Nov 2017 · 3 months · monthly snapshot~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshot~Dec 2017 – ~Feb 2018 · 2 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Sep 2018 · 2 months · monthly snapshot~Sep 2018 – ~Jan 2019 · 4 months · monthly snapshot~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~May 2019 · 2 months · monthly snapshot~May 2019 – ~Jul 2020 · 14 months · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jul 2024 · 34 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

21 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Sep 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE3

▶ Show 16 earlier versions

  1. Aug 2020 — Jan 2021 [monthly]

    Completed PHASE3

  2. Jul 2020 — Aug 2020 [monthly]

    Completed PHASE3

  3. May 2019 — Jul 2020 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  4. Mar 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  5. Jan 2019 — Mar 2019 [monthly]

    Active Not Recruiting PHASE3

  6. Sep 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE3

  7. Jul 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE3

  8. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE3

  9. Feb 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  10. Dec 2017 — Feb 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: Enrolling By Invitation → Active Not Recruiting

  11. Nov 2017 — Dec 2017 [monthly]

    Enrolling By Invitation PHASE3

  12. Aug 2017 — Nov 2017 [monthly]

    Enrolling By Invitation PHASE3

  13. May 2017 — Aug 2017 [monthly]

    Enrolling By Invitation PHASE3

  14. Mar 2017 — May 2017 [monthly]

    Enrolling By Invitation PHASE3

  15. Feb 2017 — Mar 2017 [monthly]

    Enrolling By Invitation PHASE3

  16. Jan 2017 — Feb 2017 [monthly]

    Enrolling By Invitation PHASE3

    First recorded

Sep 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • AbbVie
Data source: AbbVie

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

Study Locations

Albuquerque, United States , Alpharetta, United States , Atlanta, United States , Augusta, United States , Austin, United States , Baltimore, United States , Bay City, United States , Beavercreek, United States , Birmingham, United States , Boynton Beach, United States and 85 more locations