Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas

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

Summary

Cellular leiomyomas (CLs) are described as leiomyomas that are significantly more cellular than the surrounding myometrium, often with crowding and overlapping of nuclei. they often are soft and appear more tan or yellow and less circumscribed than the usual leiomyomas. Pre-operatively CLs can be recognized at ultrasound evaluation because they appear as hypoechoic uterine lesions. patients with hypoechoic myoma have a significantly longer surgery time after treatment with a gonadotropin-releasing hormone (GnRH) analog probably related to degenerative changes induced by this treatment. Hypoechoic CLs should be more responsive to ulipristal acetate treatment than common leiomyomas. The antiproliferative ulipristal effect, moreover, induces a condition of apoptotic necrosis that, compared to GnRH-a myxoid necrosis, probably allows an easier surgical enucleation of the tumor.

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

Details

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

Criteria

Inclusion Criteria:

• hypoechoic uterine leiomyoma (echogenicity <3),

• intramural leiomyomas with an ultrasonographic size <20 cm but >4cm,

• indication to surgery (symptoms of menometrorrhagia,

• menstrual disorder,

• infertility,

• pelvic pain or pelvic pressure

Exclusion Criteria:

• submucosal leiomyoma,

• endometrial hyperplasia with atypia,

• history of uterine surgery