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NCT03271489 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety Study 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
- 478
- Enrollment target
NCT03271489 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 478 participants.
The verdict
NCT03271489, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 478 participants
- Enrollment target
Study Summary
This randomized multicenter phase 3b study seeks to evaluate the 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 was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.
Interventions
- DRUG Elagolix
- DRUG Estradiol /norethindrone acetate (E2/NETA)
- OTHER E2/NETA Placebo
- OTHER Elagolix Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2017-09-13 |
| Est. Completion | 2024-06-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03271489
The ClinicalTrials.gov registry entry for NCT03271489 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 478 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.
NCT03271489 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03271489 about?
NCT03271489 is a clinical study titled "Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women". This randomized multicenter phase 3b study seeks to evaluate the 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 was double-blind (DB) during the first 12 months ...
What is the current status of trial NCT03271489?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2017-09-13. Estimated completion is 2024-06-28.
What interventions are being tested in trial NCT03271489?
The interventions under investigation include: Elagolix (DRUG), Estradiol /norethindrone acetate (E2/NETA) (DRUG), E2/NETA Placebo (OTHER), Elagolix Placebo (OTHER).
Who is sponsoring clinical trial NCT03271489?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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