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NCT03213457 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 681
- Enrollment target
NCT03213457 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 681 participants.
The verdict
NCT03213457, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 681 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.
Interventions
- DRUG Elagolix
- DRUG Estradiol/Norethindrone Acetate
- DRUG Placebo for Elagolix
- DRUG Placebo for E2/NETA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 681 participants |
| Start Date | 2017-07-07 |
| Est. Completion | 2023-12-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03213457
The ClinicalTrials.gov registry entry for NCT03213457 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 681 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.
NCT03213457 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03213457 about?
NCT03213457 is a clinical study titled "A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain". The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.
What is the current status of trial NCT03213457?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 681 participants. The study started on 2017-07-07. Estimated completion is 2023-12-06.
What interventions are being tested in trial NCT03213457?
The interventions under investigation include: Elagolix (DRUG), Estradiol/Norethindrone Acetate (DRUG), Placebo for Elagolix (DRUG), Placebo for E2/NETA (DRUG).
Who is sponsoring clinical trial NCT03213457?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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