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NCT02654054 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 413
- Enrollment target
NCT02654054: Completed Phase 3 study, sponsored by AbbVie.
NCT02654054 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 413 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02654054, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 413 participants
- Enrollment target
Study Summary
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
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 Reference Day, which is defined as the last visit date during the Treatment Period \[last treatment visit date\] or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date), and * ≥ 50% reduction in MBL volume from Basel
Interventions
- DRUG Elagolix
- DRUG Placebo for Estradiol/Norethindrone Acetate
- DRUG Estradiol/Norethindrone Acetate
- DRUG Placebo for Elagolix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 413 participants |
| Start Date | 2015-12-22 |
| Est. Completion | 2018-12-12 |
| Phase | Phase 3 |
What the finished NCT02654054 record still lists
NCT02654054 is an interventional study that assigns participants to a tested intervention. The registered 413 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 (47% lower).
The record links to 0 conditions, and to 4 interventions - of which Elagolix is the first listed.
NCT02654054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02654054 about?
NCT02654054 is a clinical study titled "Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women". This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
What is the current status of trial NCT02654054?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 413 participants. The study started on 2015-12-22. Estimated completion is 2018-12-12.
What interventions are being tested in trial NCT02654054?
The interventions under investigation include: Elagolix (DRUG), Placebo for Estradiol/Norethindrone Acetate (DRUG), Estradiol/Norethindrone Acetate (DRUG), Placebo for Elagolix (DRUG).
Who is sponsoring clinical trial NCT02654054?
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 NCT02654054's enrollment target sits among peer trials
413 905th of 2000 higher than 1,095 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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