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NCT02925494 · ClinicalTrials.gov registry record · Phase 3
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 433
- Enrollment target
NCT02925494: Completed Phase 3 study, sponsored by AbbVie.
NCT02925494 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 433 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02925494, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 433 participants
- Enrollment target
Study Summary
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.
Primary Outcome
Percentage of responders, defined as participants who met the following conditions: * Menstrual blood loss (MBL) volume \< 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and * ≥ 50% reduction in MBL volume from Baseline to the Final Month. Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders rega
Interventions
- DRUG Elagolix
- DRUG Estradiol/Norethindrone Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 433 participants |
| Start Date | 2016-09-14 |
| Est. Completion | 2019-03-22 |
| Phase | Phase 3 |
What the finished NCT02925494 record still lists
NCT02925494 is an interventional study that assigns participants to a tested intervention. The registered 433 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Elagolix is the first listed.
NCT02925494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02925494 about?
NCT02925494 is a clinical study titled "An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids". This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone ac...
What is the current status of trial NCT02925494?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 433 participants. The study started on 2016-09-14. Estimated completion is 2019-03-22.
What interventions are being tested in trial NCT02925494?
The interventions under investigation include: Elagolix (DRUG), Estradiol/Norethindrone Acetate (DRUG).
Who is sponsoring clinical trial NCT02925494?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02925494's enrollment target sits among peer trials
433 876th of 2000 higher than 1,125 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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