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

Phase 4

• Conditions: Fibroid
• Interventions: Drug: Leuprolide acetate; Drug: ulipristal acetate

• Registration Number: NCT02361879
• Lead Sponsor: University Magna Graecia

Brief 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.

Detailed Description

The uterine leiomyoma is the most common benign tumor of the female genital tract. The myomas are usually clinically apparent in 25% of patients. Submucosal fibroid are about 10% of all uterine myoma; they distort the endometrial cavity causing heavy and/or irregular bleeding (AUB) and infertility. According to the degree of myometrial penetration, the European Society for Gynaecological Endoscopy (ESGE) classified submucosal myomas in Type 0 (totally intracavitary fibroids), Type I (\<50% myometral penetration), or Type II (\>50% myometral penetration).

Hysteroscopic removal of submucosal myomas improves menorrhagia and AUB. 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. A recent meta-analysis of data demonstrated that symptomatic relief in patients undergoing surgery was similar either following pre-operative GnRH-a administration or without GnRH-a administration, mainly due to the persistence of abnormal bleeding due to the protrusion of the myoma into the uterine cavity.

In recent studies, Ulipristal acetate treatment was able to control uterine bleeding associated with fibroids in more than 90% of cases. Moreover, it controlled bleeding faster than GnRH agonists, with median times to amenorrhea of 5-7 days in patients receiving UPA compared to 21 days in patients receiving a GnRH agonist. It was demonstrated that UPA significantly improved also quality of life. Pain, as measured by the visual analogue scale, showed a degree of relief similar to that achieved for postoperative pain with narcotic and non-narcotic analgesics. This pain reduction is related to the high amenorrhea rate during treatment (severe bleeding being responsible for uterine contractions and prostaglandin secretion). No sub-analysis have been conducted on submucosal fibroids but, according to our experience, this subgroup of myomas may be the one who most benefits from the administration of UPA.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-02
• Study First Submitted QC: 2015-02-08
• Study First Posted: 2015-02-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leuprolile acetate	Leuprolide acetate	women will be treated with 1 IM injection of leuprolide acetate 11,25 mg in in the luteal phase
Ulipristal acetate	ulipristal acetate	Womens will be treated with 5 mg/day of oral ulipristal acetate for 3 months

Primary Outcome Measures

Name	Time	Method
Uterine bleeding assessed by pictorial blood-loss assessment chart (PBAC)	90 days after the beginning of the treatment	To compare the proportion of controlled uterine bleeding in patients with submucous myoma preoperatively treated by ulipristal acetate or by GnRh-a

Secondary Outcome Measures

Name	Time	Method
Fluid absorption	Within 2 hours after the end of the hysteroscopy	It will be expressed in mL
Feasibility of myoma hysteroscopic resection (VAS score)	Within 2 hours after the end of the hysteroscopy	Surgeon experience about the hysteroscopy
Haemoglobin concentration	The day before and 3 hours after the hysteroscopy	It will be expressed in mg/dL
Operative time	Within 2 hours after the end of the hysteroscopy	It will be expressed in minutes

Trial Locations

Locations (1)

Azienda Ospedaliera Pugliese-Ciaccio; 🇮🇹 Catanzaro, Italy