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

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ClinicalTrials.gov Identifier: NCT02361879
Recruitment Status : Unknown
Verified November 2016 by Fulvio Zullo, University Magna Graecia.
Recruitment status was:  Recruiting
First Posted : February 12, 2015
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Fulvio Zullo, University Magna Graecia

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.

Condition or disease Intervention/treatment Phase
Fibroid Drug: ulipristal acetate Drug: Leuprolide acetate Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma
Study Start Date : February 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ulipristal acetate
Womens will be treated with 5 mg/day of oral ulipristal acetate 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 Name: Esmya

Active Comparator: Leuprolile acetate
women will be treated with 1 IM injection of leuprolide acetate 11,25 mg in 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 Name: Enantone 11.25




Primary Outcome Measures :
  1. Uterine bleeding assessed by pictorial blood-loss assessment chart (PBAC) [ Time Frame: 90 days after the beginning of the treatment ]
    To compare the proportion of controlled uterine bleeding in patients with submucous myoma preoperatively treated by ulipristal acetate or by GnRh-a


Secondary Outcome Measures :
  1. Feasibility of myoma hysteroscopic resection (VAS score) [ Time Frame: Within 2 hours after the end of the hysteroscopy ]
    Surgeon experience about the hysteroscopy

  2. Operative time [ Time Frame: Within 2 hours after the end of the hysteroscopy ]
    It will be expressed in minutes

  3. Haemoglobin concentration [ Time Frame: The day before and 3 hours after the hysteroscopy ]
    It will be expressed in mg/dL

  4. Fluid absorption [ Time Frame: Within 2 hours after the end of the hysteroscopy ]
    It will be expressed in mL



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361879


Contacts
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Contact: Fulvio Zullo, MD,PhD 00390961883234 zullo@unicz.it
Contact: Roberta Venturella, MD 00390961883401 rovefa@libero.it

Locations
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Italy
Azienda Ospedaliera Pugliese-Ciaccio Recruiting
Catanzaro, Italy, 88100
Contact: Fulvio Zullo, MD,PhD    00390961883234    zullo@unicz.it   
Principal Investigator: Roberta Venturella, MD         
Sponsors and Collaborators
University Magna Graecia
Investigators
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Study Director: Fulvio Zullo, MD,PhD Magna Graecia University of Catanzaro
Principal Investigator: Roberta Venturella, MD Magna Graecia University of Catanzaro

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Responsible Party: Fulvio Zullo, Full professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT02361879     History of Changes
Other Study ID Numbers: UPA and hysteroscopy
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Fulvio Zullo, University Magna Graecia:
fibroids
gnrh analogue
ulipristal acetate
hysteroscopy
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Leuprolide
Ulipristal acetate
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents, Female
Contraceptive Agents