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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: Completed Phase 3 study, sponsored by AbbVie.
NCT03213457 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 681 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do *
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 |
What the finished NCT03213457 record still lists
NCT03213457 is an interventional study that assigns participants to a tested intervention. The registered 681 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 (12% lower).
The record links to 0 conditions, and to 4 interventions - of which Elagolix is the first listed.
NCT03213457 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03213457's enrollment target sits among peer trials
681 530th of 2000 higher than 1,469 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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