Trials / Completed
CompletedNCT00100191
Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids
EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (planned)
- Sponsor
- ZonMw: The Netherlands Organisation for Health Research and Development · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE was considered equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment.
Detailed description
Uterine Artery Embolization (UAE) is a new treatment for heavy menstrual bleeding caused by uterine fibroids. UAE is already being performed on a regular basis, without profound evidence: no good quality randomized controlled trials have been conducted. The EMMY trial evaluates the safety and efficacy of UAE in a randomized comparison to hysterectomy. Patients were included when they had uterine fibroids and menorrhagia, and were eligible for hysterectomy. The primary endpoint is the elimination of menorrhagia after a two-year follow-up period. Secondary endpoints comprise: effect on complaints of pain and pressure, quality of life issues, uterine volume reduction, effect on ovarian function and cost-effectiveness. Patients were randomly assigned to either UAE or hysterectomy (1:1). All patients were followed for two years after treatment. Whether UAE can be an alternative to hysterectomy as treatment of first choice depends on the balance of efficacy, costs, and quality of life.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | uterine artery embolization | |
| PROCEDURE | hysterectomy |
Timeline
- Start date
- 2002-02-01
- Completion
- 2006-04-01
- First posted
- 2004-12-24
- Last updated
- 2005-06-24
Locations
2 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT00100191. Inclusion in this directory is not an endorsement.