Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas

November 17, 2016 updated by: Fulvio Zullo, University Magna Graecia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • Recruiting
        • Azienda Ospedaliera Pugliese-Ciaccio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ulipristal acetate
women will be treated with an oral dose of ulipristal acetate 5 mg/day for 3 months
Drug: ulipristal acetate
5 mg/day will be administered starting from day 1 of the cycle and up to three months later
Other Names:
  • Esmya
Active Comparator: Leuprolile acetate
Women will be treated with an intramuscular (IM) injection of leuprolide acetate 11.25 mg in the luteal phase
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)
Other Names:
  • Enantone 11.25

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time (minutes)
Time Frame: At the time of skin closure at the end of the myomectomy
To 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 .
At the time of skin closure at the end of the myomectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difficulty of leiomyoma enucleation assessed by surgeon on a VAS scale
Time Frame: Within 2 hours after the end of the myomectomy
To compare surgical feasibility (VAS) in patients treated with Ulipristal Acetate and GnRH-a.
Within 2 hours after the end of the myomectomy
Intraoperative blood loss (delta Hb)
Time Frame: The day before surgery and 3 hours after the myomectomy
To compare blood loss (delta HB) in patients treated with Ulipristal Acetate and GnRH-a.
The day before surgery and 3 hours after the myomectomy
Post-operative evaluation of leiomyomas characteristics
Time Frame: At the time of pathological assessment
This is a composite outcome aimed to compare pathological myoma characteristics (cellularity, necrosis, fibrosis) in patients treated with Ulipristal Acetate and GnRH-a.
At the time of pathological assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Magna Graecia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

February 8, 2015

First Posted (Estimate)

February 12, 2015

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPA hypoecoic myomas

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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