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NCT03343067 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
A Phase 3 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 3
- Development phase
- 11
- Enrollment target
NCT03343067: Clinical Trial Phase 3 study, sponsored by AbbVie.
NCT03343067 is a Phase 3 study that was terminated before completion, run by AbbVie. The registered enrollment target is 11 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03343067, a Phase 3 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both elagolix alone and elagolix plus estradiol/norethindrone acetate (E2/NETA) over 24 months in the management of endometriosis with associated moderate to severe pain in premenopausal women.
Primary Outcome
Proportion of responders at Month 6 based upon the scale for DYS pain scale (ranging from 0 \[none\] to 3 \[severe\]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.
Interventions
- DRUG elagolix
- DRUG estradiol/norethindrone acetate (E2/NETA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-12-27 |
| Est. Completion | 2018-10-23 |
| Phase | Phase 3 |
Why NCT03343067 stopped before completion
NCT03343067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which elagolix is the first listed.
NCT03343067 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03343067 about?
NCT03343067 is a clinical study titled "A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain". This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both elagolix alone and elagolix plus estradiol/norethindrone acetate (E2/NETA) over 24 months in the management of endometriosis with associated moderate to severe pain in premenopausal women.
What is the current status of trial NCT03343067?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 11 participants. The study started on 2017-12-27. Estimated completion is 2018-10-23.
What interventions are being tested in trial NCT03343067?
The interventions under investigation include: elagolix (DRUG), estradiol/norethindrone acetate (E2/NETA) (DRUG).
Who is sponsoring clinical trial NCT03343067?
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 NCT03343067's enrollment target sits among peer trials
11 1989th of 2000 higher than 12 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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