Clinical trial NCT02361879: Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma
Official title: Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fibroid
Keywords: fibroids
gnrh analogue
ulipristal acetate
hysteroscopy
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Uterine bleeding assessed by pictorial blood-loss assessment chart (PBAC)
timeFrame: 90 days after the beginning of the treatment
Secondary outcomes:
measure: Feasibility of myoma hysteroscopic resection (VAS score)
timeFrame: Within 2 hours after the end of the hysteroscopy
measure: Operative time
timeFrame: Within 2 hours after the end of the hysteroscopy
measure: Haemoglobin concentration
timeFrame: The day before and 3 hours after the hysteroscopy
measure: Fluid absorption
timeFrame: Within 2 hours after the end of the hysteroscopy
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Pugliese-Ciaccio
Study officials:
affiliation: Magna Graecia University of Catanzaro
name: Fulvio Zullo, MD,PhD
role: STUDY_DIRECTOR
affiliation: Magna Graecia University of Catanzaro
name: Roberta Venturella, MD
role: PRINCIPAL_INVESTIGATOR
References: