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Ulipristal Acetate Versus GnRH Analogue and Myometrial Preservation

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ClinicalTrials.gov Identifier: NCT02357563
Recruitment Status : Unknown
Verified November 2016 by Fulvio Zullo, University Magna Graecia.
Recruitment status was:  Recruiting
First Posted : February 6, 2015
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Fulvio Zullo, University Magna Graecia

Brief Summary:
Submucosal fibroid grow inside the uterine cavity and are associated with menorrhagia, abnormal uterine bleeding (AUB) and infertility. Type II (G2) fibroids often require more surgeries due to their particular position in the myometrium. Surgery, moreover, should always be tailored, particularly in patients wishing to conceive, to preserve the integrity of the myometrium. Preoperative use of GnRH agonist appears to be relevant and beneficial in patients with submucous fibroids, but are associated with several side effects. the eighty percent of patients treated by UPA showed a clinically meaningful reduction of more than 25% in fibroid volume, and 50% of patients a reduction of 50%. fibroid volume reduction appeared to be maintained for 6 months after the end of UPA treatment

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

Detailed Description:

Uterine leiomyoma is the most common benign tumor of the female genital tract. Submucosal fibroid are about 10% of all uterine myoma. They grow inside the uterine cavity and are usually associated with menorrhagia, abnormal uterine bleeding (AUB) and infertility. According to the degree of myometrial penetration, the European Society for Gynaecological Endoscopy (ESGE) classified submucosal myomas in Type 0 (G0, totally intracavitary fibroids), Type I (G1, <50% myometral penetration), or Type II (G2, >50% myometral penetration).

Hysteroscopic removal of submucosal myomas improves menorrhagia and AUB but can be challenging in women with Type II (G2) fibroids, since they often require more and more surgeries due to their particular position in the context of myometrium. Surgery, moreover, should always be tailored, particularly in patients wishing to conceive, to preserve the integrity of the myometrium. In this particular population, indeed, the possibility of avoiding any kind of uterine surgery should always be exploited. Up to now, hysteroscopic resection of submucosal fibroids is considered the gold standard for symptomatic patients, since no medication has been able to restore uterine cavity in a permanent manner. In this setting, use of a GnRH agonist before surgery is still a matter of debate, but literature reports that preoperative use of GnRH agonist appears to be relevant and beneficial in patients with submucous fibroids. Benefits include a resolution of preoperative anemia, a decrease in fibroid size, a reduction of endometrial thickness and vascularization with subsequently improved visibility and reduced fluid absorption, and the possibility of surgical scheduling.

Conversely, this preoperative treatment is associated with some side effects such as hot flushes and postinjection endometrial bleeding due to the flare-up effect.

Data on SPRM showed that eighty percent of patients treated by UPA showed a clinically meaningful reduction of more than 25% in fibroid volume, and 50% of patients a reduction of 50%. In the subpopulation of patients not undergoing surgery, fibroid volume reduction appeared to be maintained for 6 months after the end of UPA treatment.

This was in contrast to patients receiving a GnRH agonist, in whom fibroids began to regrow 1 to 3 months after the last dose, reaching their baseline size after 6 months.

No sub-analysis have been conducted on submucosal fibroids, but is of interest to underline that, when myomas regress so much that they no longer distort the uterine cavity, surgery may not be required. This could represent a safe way to avoid surgery in patients with G2 fibroids desiring pregnancy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ulipristal Acetate Versus GnRH Analogue for Myometrial Preservation in Patients With Submucosal Uterine Leiomyoma G2
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
Women will be treated with an oral dose of ulipristal acetate 5 mg/day for 2 courses of 3 months each
Drug: ulipristal acetate
5 mg/day will be administered starting from day 1 of the cycle and up to three months later for two courses, with an interval between the courses of 1 month
Other Name: Esmya

Active Comparator: Leuprolile acetate
Women will be treated with an injection IM on leuprolide acetate 11,25 in the luteal phase repeated 3 months later
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) and repeated 3 months later
Other Name: Enantone 11.25




Primary Outcome Measures :
  1. Proportion of restored uterine cavity 1 year after enrollment [ Time Frame: 1 year after treatment ]
    To compare the proportion of patients, treated by UPA or by GnRh-a, with uterine cavity no longer distorted by their submucous myoma


Secondary Outcome Measures :
  1. Time to pregnancy [ Time Frame: from the end of treatment to the obtainance of pregnancy ]
    to compare time to pregnancy in patients treated with Ulipristal Acetate and GnRH-a

  2. Live birth rate [ Time Frame: A the time of delivery ]
    to compare live birth rate in patients treated with Ulipristal Acetate and GnRH-a

  3. Proportion of patients needing surgery after UPA or GnRH-a [ Time Frame: 24 weeks after the first dose of drugs ]
    to compare need for surgery in patients treated with Ulipristal Acetate and GnRH-a.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

G2 submucosal leiomyoma <3 cm, symptoms of menomethrorragia, menstrual disorder, infertility, pelvic pain

Exclusion Criteria:

submucosal leyomyoma other than G2 or greater than 3 cm, 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): NCT02357563


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    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: NCT02357563    
Other Study ID Numbers: UPA myometrial
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Fulvio Zullo, University Magna Graecia:
fibroid
GnRH analogue
ulipristal acetate
Additional relevant MeSH terms:
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Leiomyoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
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