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

NCT ID: NCT02361879

Last Updated: 2016-11-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-09-30

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.

Conditions

Fibroid

Keywords

fibroids; gnrh analogue; ulipristal acetate; hysteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ulipristal acetate

Womens will be treated with 5 mg/day of oral ulipristal acetate for 3 months

Group Type: EXPERIMENTAL

ulipristal acetate

Intervention Type: DRUG

5 mg/day will be administered starting from day 1 of the cycle and up to three months later

Leuprolile acetate

women will be treated with 1 IM injection of leuprolide acetate 11,25 mg in in the luteal phase

Group Type: ACTIVE_COMPARATOR

Leuprolide acetate

Intervention Type: DRUG

One dose of 11.25 GnRH analogue depot will be administered in the luteal phase of the menstrual cycle (days 21-24)

Interventions

ulipristal acetate

5 mg/day will be administered starting from day 1 of the cycle and up to three months later

Intervention Type: DRUG

Leuprolide acetate

One dose of 11.25 GnRH analogue depot will be administered in the luteal phase of the menstrual cycle (days 21-24)

Intervention Type: DRUG

Other Intervention Names

Esmya; Enantone 11.25

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Fulvio Zullo

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fulvio Zullo, MD,PhD

Role: STUDY_DIRECTOR

Magna Graecia University of Catanzaro

Roberta Venturella, MD

Role: PRINCIPAL_INVESTIGATOR

Magna Graecia University of Catanzaro

Locations

Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, Catanzaro, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fulvio Zullo, MD,PhD

Role: CONTACT

Phone: 00390961883234

Email: zullo@unicz.it

Roberta Venturella, MD

Role: CONTACT

Phone: 00390961883401

Email: rovefa@libero.it

Facility Contacts

Fulvio Zullo, MD,PhD

Role: primary

Other Identifiers

UPA and hysteroscopy

Identifier Type: -

Identifier Source: org_study_id