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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 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 413 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02654054
The ClinicalTrials.gov registry entry for NCT02654054 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 413 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Elagolix is the first listed.
NCT02654054 reports 0 study locations.
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.
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