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Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas

Advantages of Ulipristal Acetate for the Preoperative Treatment of Hypoechoic Cellular Leiomyomas

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02361905
Enrollment
42
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

fibroid, cellular leiomyomas, GnRH analogue, ulipristal acetate

Brief 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.

Detailed description

Rationale why study should be conducted: Leiomyomas are the most common benign neoplasm in women; it has been estimated that these tumors occur in at least 25% of all women, which is probably an underestimation, because this figure is based on a select population. They are histologically composed by smooth muscle cells with bland, uniform, cigar-shaped nuclei that are arranged in interlacing bundles, showing little or no mitotic activity. Cellular leiomyomas (CLs) are described as leiomyomas that are significantly more cellular than the surrounding myometrium, often with crowding and overlapping of nuclei. The presenting symptoms do not differ from those of patients with typical leiomyomas. On gross examination, CLs are more often soft and appear more tan or yellow and less circumscribed than the usual leiomyomas. Pre-operatively, anyway, CLs can be recognized at ultrasound evaluation because they appear as hypoechoic uterine lesions. It has been demonstrated that patients with hypoechoic myoma have a significantly longer surgery time after treatment with a GnRH analog than for the rest of the pretreated fibroids or the untreated patients with hypoechoic myomas. Considering the predominant relevance of the traction maneuvers in laparoscopic myomectomy, the difficulty in adequately grasping the tumor is the key element in the longer operative time. The greater softening of the fibroid tissue is probably related to degenerative changes induced by the GnRH-analog pretreatment, particularly in those fibroids without an adequate fibrous skeleton and thus with the appearance as hypoechoic at the admission ultrasonography. From a pathologic point of view, these fibroids, when pretreated, showed a predominance of areas of coagulative necrosis and mixoid degeneration, causing longer operative time and showing unequivocally the negative effect of preoperative GnRH analog treatment for these kinds of uterine fibroids. At the same time, hypoechoic CLs should be more responsive to ulipristal acetate treatment than common leiomyomas, given its antiproliferative activity in cultured leiomyoma cells. 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.

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
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Operative time (minutes)At the time of skin closure at the end of the myomectomyTo evaluate the difference in terms of operative times in patients with hypoechoic CLs submitted to laparoscopic myomectomy and preoperatively treated by ulipristal acetate or GnRh-a .

Secondary

MeasureTime frameDescription
Difficulty of leiomyoma enucleation assessed by surgeon on a VAS scaleWithin 2 hours after the end of the myomectomyTo compare surgical feasibility (VAS) in patients treated with Ulipristal Acetate and GnRH-a.
Intraoperative blood loss (delta Hb)The day before surgery and 3 hours after the myomectomyTo compare blood loss (delta HB) in patients treated with Ulipristal Acetate and GnRH-a.
Post-operative evaluation of leiomyomas characteristicsAt the time of pathological assessmentThis is a composite outcome aimed to compare pathological myoma characteristics (cellularity, necrosis, fibrosis) in patients treated with Ulipristal Acetate and GnRH-a.

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