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	Treatment or Intervention	Phase
Menorrhagia Leiomyoma Uterine Neoplasms	Procedure: uterine artery embolization  Procedure: hysterectomy	Phase III

Further Study Details: 

Primary Outcomes: The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
Secondary Outcomes: Effect on complaints of pain and pressure; Technical failure; Complications; Quality of life issues; Uterine volume reduction; Effect on ovarian function; Cost-effectiveness
Expected Total Enrollment:  120

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

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)

Netherlands
      Academic Medical Centre Amsterdam, Amsterdam,  1105 AZ,  Netherlands
      27 Other Participating Hospitals of Varying Sizes Throughout the Country, Amsterdam,  Netherlands

Study chairs or principal investigators

J.A. Reekers, MD, PhD,  Principal Investigator,  Academic Medical Centre, Department of Radiology   

Study ID Numbers:  NWO-DO 945-01-17
Record last reviewed:  December 2004
Last Updated:  December 28, 2004
Record first received:  December 23, 2004
ClinicalTrials.gov Identifier:  NCT00100191
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08