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NCT03886220 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
A Phase 4 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 4
- Development phase
- 82
- Enrollment target
NCT03886220: Completed Phase 4 study, sponsored by AbbVie.
NCT03886220 is a Phase 4 study that has completed, run by AbbVie. The registered enrollment target is 82 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03886220, a Phase 4 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 82 participants
- Enrollment target
Study Summary
The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.
Primary Outcome
Responders were defined as participants meeting the following 2 conditions: * menstrual blood loss (MBL) volume \< 80 mL at the Final Month (defined as the last 28 days prior to and including the last dose day), and * 50% or greater reduction in MBL volume from Baseline to the Final Month. Participants whose primary reason for prematurely discontinuing study drug was "lack of efficacy," or "requires surgery or invasive intervention for treatment of uterine fibroids" were considered as non-resp
Interventions
- DRUG Placebo
- DRUG Elagolix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2019-04-12 |
| Est. Completion | 2021-04-28 |
| Phase | Phase 4 |
What the finished NCT03886220 record still lists
NCT03886220 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03886220 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03886220 about?
NCT03886220 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women". The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibr...
What is the current status of trial NCT03886220?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 82 participants. The study started on 2019-04-12. Estimated completion is 2021-04-28.
What interventions are being tested in trial NCT03886220?
The interventions under investigation include: Placebo (DRUG), Elagolix (DRUG).
Who is sponsoring clinical trial NCT03886220?
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 NCT03886220's enrollment target sits among peer trials
82 939th of 2000 higher than 1,061 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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