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Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00100191
Recruitment Status : Completed
First Posted : December 24, 2004
Last Update Posted : June 24, 2005
Boston Scientific Corporation
Information provided by:
ZonMw: The Netherlands Organisation for Health Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Menorrhagia Leiomyoma Uterine Neoplasms Procedure: uterine artery embolization Procedure: hysterectomy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids
Study Start Date : February 2002
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Primary Outcome Measures :
  1. The primary endpoint is the normalization of menorrhagia after a two-year follow-up period

Secondary Outcome Measures :
  1. Effect on complaints of pain and pressure
  2. Technical failure
  3. Complications
  4. Quality of life issues
  5. Uterine volume reduction
  6. Effect on ovarian function
  7. Cost-effectiveness

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Uterine fibroids
  • Menorrhagia
  • Scheduled for hysterectomy
  • Pre-menopausal

Exclusion Criteria:

  • Childwish (planning to conceive)
  • Pregnancy
  • Suspected malignancy
  • Untreated pelvic inflammatory disease (PID)
  • Clotting disorders
  • Contrast fluid allergy
  • Presence of intrauterine device (IUD)
  • Renal failure (creatinine > 150 mmol/l)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00100191

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Academic Medical Centre Amsterdam
Amsterdam, Netherlands, 1105 AZ
27 Other Participating Hospitals of Varying Sizes Throughout the Country
Amsterdam, Netherlands
Sponsors and Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
Boston Scientific Corporation
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Principal Investigator: J.A. Reekers, MD, PhD Academic Medical Centre, Department of Radiology

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00100191     History of Changes
Other Study ID Numbers: NWO-DO 945-01-17
First Posted: December 24, 2004    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2004
Keywords provided by ZonMw: The Netherlands Organisation for Health Research and Development:
uterine artery embolization
therapeutic embolization
Additional relevant MeSH terms:
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Uterine Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Menstruation Disturbances
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site