Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00100191
Other study ID # NWO-DO 945-01-17
Secondary ID
Status Completed
Phase Phase 3
First received December 23, 2004
Last updated June 23, 2005
Start date February 2002
Est. completion date April 2006

Study information

Verified date December 2004
Source ZonMw: The Netherlands Organisation for Health Research and Development
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
uterine artery embolization

hysterectomy


Locations

Country Name City State
Netherlands 27 Other Participating Hospitals of Varying Sizes Throughout the Country Amsterdam
Netherlands Academic Medical Centre Amsterdam Amsterdam

Sponsors (2)

Lead Sponsor Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development Boston Scientific Corporation

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Hehenkamp WJ, Volkers NA, Van Swijndregt AD, De Blok S, Reekers JA, Ankum WM. Myoma expulsion after uterine artery embolization: complication or cure? Am J Obstet Gynecol. 2004 Nov;191(5):1713-5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
Secondary Effect on complaints of pain and pressure
Secondary Technical failure
Secondary Complications
Secondary Quality of life issues
Secondary Uterine volume reduction
Secondary Effect on ovarian function
Secondary Cost-effectiveness
See also
  Status Clinical Trial Phase
Completed NCT02824224 - Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) Phase 4
Withdrawn NCT01651468 - The Effect of the Nutraceutical "Hemofix" on the Coagulation System N/A
Recruiting NCT02616731 - Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD Phase 1/Phase 2
Terminated NCT02087228 - Evaluation of the Endometrial Cavity After Endometrial Ablation N/A
Withdrawn NCT00953641 - Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy Phase 3
Completed NCT01436903 - Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length Phase 4
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00156195 - Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Completed NCT00160381 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
Completed NCT02228174 - Sonography Guided Transcervical Ablation of Uterine Fibroids N/A
Terminated NCT01969396 - Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology N/A
Completed NCT00386308 - Efficacy and Safety Study of XP12B in Women With Menorrhagia Phase 3
Completed NCT00393198 - Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia Phase 4
Completed NCT00966264 - Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia Phase 3
Completed NCT00904709 - The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders Phase 4
Recruiting NCT03670680 - Efficiency of Lina LibrataTM System N/A
Completed NCT02584088 - Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation
Completed NCT02835391 - PerClot Compared to Usual Care in Gynaecology Procedures N/A
Completed NCT02304510 - Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing