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

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by:
ZonMw: The Netherlands Organisation for Health Research and Development
ClinicalTrials.gov Identifier:
NCT00100191
First received: December 23, 2004
Last updated: June 23, 2005
Last verified: December 2004
History of Changes
  Purpose

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 Intervention Phase
Menorrhagia
Leiomyoma
Uterine Neoplasms
 Procedure: uterine artery embolization
Procedure: hysterectomy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ZonMw: The Netherlands Organisation for Health Research and Development:

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

Secondary Outcome Measures:
  • Effect on complaints of pain and pressure
  • Technical failure
  • Complications
  • Quality of life issues
  • Uterine volume reduction
  • Effect on ovarian function
  • Cost-effectiveness

Estimated Enrollment: 120
Study Start Date: February 2002
Estimated Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100191

Locations
Netherlands
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
Investigators
Principal Investigator: J.A. Reekers, MD, PhD Academic Medical Centre, Department of Radiology
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00100191     History of Changes
Other Study ID Numbers: NWO-DO 945-01-17
Study First Received: December 23, 2004
Last Updated: June 23, 2005
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by ZonMw: The Netherlands Organisation for Health Research and Development:
hysterectomy
fibroids
uterine artery embolization
 therapeutic embolization
uterus
menorrhagia

Additional relevant MeSH terms:
Neoplasms
Leiomyoma
Myofibroma
Menorrhagia
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
Menstruation Disturbances
Pathologic Processes
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 16, 2013