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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02361879
Enrollment
146
Registered
2015-02-12
Start date
2015-02-28
Completion date
2017-09-30
Last updated
2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibroid

Keywords

fibroids, gnrh analogue, ulipristal acetate, hysteroscopy

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.

Interventions

DRUGulipristal acetate

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

DRUGLeuprolide acetate

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

Sponsors

University Magna Graecia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Feasibility of myoma hysteroscopic resection (VAS score)Within 2 hours after the end of the hysteroscopySurgeon experience about the hysteroscopy
Operative timeWithin 2 hours after the end of the hysteroscopyIt will be expressed in minutes
Haemoglobin concentrationThe day before and 3 hours after the hysteroscopyIt will be expressed in mg/dL
Fluid absorptionWithin 2 hours after the end of the hysteroscopyIt will be expressed in mL

Countries

Italy

Contacts

Primary ContactFulvio Zullo, MD,PhD
zullo@unicz.it00390961883234
Backup ContactRoberta Venturella, MD
rovefa@libero.it00390961883401

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026