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NCT00821275 Clinical Trial

Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

Leiomyoma Clinical Trial

Official title:
Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00821275
Other study ID # 2007026
Secondary ID
Status Enrolling by invitation
Phase Phase 2/Phase 3
First received January 9, 2009
Last updated January 9, 2009
Start date January 2008
Est. completion date December 2018

Study information
Verified date January 2009
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 900
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 50 Years
Eligibility 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.

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:
• 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.

Locations
Country Name City State
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Nanfang Hospital of Nanfang medical University Guangzhou Guangdong
China Sun Yat-sen University Guangzhou Guangdong
China the first Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary quality of life 1,3,5,10 year. No
Primary pregnant 3 years No
Secondary tumor recurrence 1,3,5,10 years No
Secondary complications 3,6,12,24 months No
Secondary ovarian functions 3,6,12 months, 2,3,5 and 10 years No
Secondary symptom relief 3,6,12,24 months No
Secondary tumour volume 3,6,12 18 24 months and 3,5,10 years No
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Completed NCT00156195 - Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
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Completed NCT00044876 - Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist Phase 2
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Completed NCT00156156 - Study of Asoprisnil in the Treatment of Uterine Fibroids. Phase 3
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Active, not recruiting NCT03323905 - Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas N/A
Terminated NCT03342859 - Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned Phase 1
Recruiting NCT06135870 - Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)
Completed NCT02777203 - Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy N/A
Completed NCT02189083 - Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids Phase 3
Completed NCT01123603 - Lower Urinary Tract Infection (UTI) Evaluation in Women With Uterine Leiomyomata N/A

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