Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The uterine leiomyoma is the most common female benign disease. Submucosal fibroid are about 10%, they distort the endometrial cavity causing heavy and/or irregular bleeding (AUB) and infertility. Hysteroscopic removal of submucosal myomas improves this conditions. GnRH analogues are commonly used before hysteroscopic myomectomy to make surgery easier and safer, but they are expensive, have potential side effects and lack a robust evidence base to support this practice. Ulipristal acetate treatment was able and faster to control in 90% of cases uterine bleeding associated with fibroids than GnRH agonists. UPA significantly improved quality of life and pain reduction.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Magna Graecia
• Treatments: Leuprolide; Ulipristal acetate

Criteria

Inclusion Criteria: submucosal leiomyoma, symptoms of menomethrorragia, menstrual disorder, infertility, pelvic pain.

Exclusion Criteria: intramural or subserosal leiomyomas, endometrial hyperplasia with atypia, history of uterine surgery