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Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00821275
First received: January 9, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

The efficacy and safety of uterine artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief, complication, fertility, ovarian function and quality of life with uterine artery embolization for uterine fibroids comparing with standard surgical methods.


Condition Intervention Phase
Leiomyoma
 Procedure: Interventional radiological or surgical management
 Phase 2
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: Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • quality of life [ Time Frame: 1,3,5,10 year. ] [ Designated as safety issue: No ]
  • pregnant [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tumor recurrence [ Time Frame: 1,3,5,10 years ] [ Designated as safety issue: No ]
  • complications [ Time Frame: 3,6,12,24 months ] [ Designated as safety issue: No ]
  • ovarian functions [ Time Frame: 3,6,12 months, 2,3,5 and 10 years ] [ Designated as safety issue: No ]
  • symptom relief [ Time Frame: 3,6,12,24 months ] [ Designated as safety issue: No ]
  • tumour volume [ Time Frame: 3,6,12 18 24 months and 3,5,10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: January 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pregnancy expectation
The patients who desire for future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group.
 Procedure: Interventional radiological or surgical management
Uterine artery embolization will be done for the patients who enroll into UAE group and desire for future pregancy and reserving uterus.Myomectomy will be performed for the patients who enroll into SURGERY group and desire for future pregancy and reserving uterus.Hysterectomy will be done for the patients who enroll into SURGERY group and don't desire for reserving uterus and/or future pregnancy.
Active Comparator: No pregnancy expectation
The patients who don't desire for reserving uterus and/ or future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group.
 Procedure: Interventional radiological or surgical management
Uterine artery embolization will be done for the patients who enroll into UAE group and desire for future pregancy and reserving uterus.Myomectomy will be performed for the patients who enroll into SURGERY group and desire for future pregancy and reserving uterus.Hysterectomy will be done for the patients who enroll into SURGERY group and don't desire for reserving uterus and/or future pregnancy.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of symptomatic uterine leiomyoma

Exclusion Criteria:

  • pregnancy
  • iodine agent allergy
  • patient refuse to take part in this trial
  • tumour size is less than 3cm or beyond 10cm
  • with endometriosis
  • with malignant diseases
  • with abnormal coagulation function which can't restore
  • with acute inflammatory diseases or acute episode of chronic inflammatory diseases
  • with severe heart, lung, liver and kidney, et al. organ diseases.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821275

Locations
China, Guangdong
Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
the first Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510089
Nanfang Hospital of Nanfang medical University
Guangzhou, Guangdong, China, 510000
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Hong Shan, M.D., PHD. Third Affiliated Hospital, Sun Yat-Sen University
  More Information

Additional Information:
The Third Affiliated Hospital of Sun Yat-sen University  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hong Shan, the third Affiliated Hospital of Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00821275     History of Changes
Other Study ID Numbers: 2007026
Study First Received: January 9, 2009
Last Updated: January 9, 2009
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
Uterine Artery Embolization
Leiomyoma
myomectomy
hysterectomy
 pregnancy
complication
ovarian function
quality of life

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 22, 2013