A phase I/II study of uterine artery embolization using gelatine sponge for symptomatic uterine leiomyoma (JIVROSG-0302)

Phase 1

• Conditions: Symptomatic uterine leimoyoma

• Registration Number: JPRN-C000000039
• Lead Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)

Brief Summary

Technical success was achieved in all patients. -Median follow-up period was 33 months. -Minor AEs occurred in 10 pts (33%) and major AEs in two (6%). The most common AE was transient amenorrhea. -Median hospital stay was five days. -The rates of symptom improvement at 12 months were: menorrhagia, 90%; pelvic pain,77%;bulk-related symptoms, 96%. -The mean reduction rate in leiomyoma volume on MRI at 12 month was 61%. : Presented at SIR 2008, Washington D.C.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-05
• Study Completion: 2007-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

1) Pregnant, nursing, or desiring future pregnancy. 2) Active pelvic inflammatory disease. 3) Pelvic malignancy. 4) Previous hormonal therapy within 12 weeks. 5) Contraindication to MRI. 6) Contraindication to iodized contrast material. 7) Uncontrolled cardiac, respiratory, gastrointestinal, or nervous disorders. Uncontrolled diabetes, hypertension, or infection. 8) Adenomyosis confirmed with MRI.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events

Secondary Outcome Measures

Name	Time	Method
Improvement of symptoms, decrease of the volume of leiomyoma, changes in ovarian function, length of hospital stay.