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Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy

NCT ID: NCT02288130

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-11-30

Brief Summary

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Rationale: Laparoscopic myomectomy is increasingly performed over laparotomic myomectomy, because of the many benefits for the patient in terms of pain, hospital stay and recovery. In order to increase the success rate of a laparoscopic procedure pre-treatment to decrease the volume might be beneficial. Gonadotropin-releasing hormone agonists (GnRHa) are used for this purpose with good results in terms of volume reduction, but sometimes resulting in loss of distinction of the right surgical planes. Ulipristal is a new pre-operative treatment option for symptomatic fibroids, which has demonstrated good results in terms of volume reduction. The effect on cleavage planes is unknown. This study is performed to evaluate if Ulipristal is as effective as GnRHa in terms of surgical outcome.

Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of intra-operative blood-loss (primary outcome), surgical time, surgical ease, complications, quality of life and costs.

Study design: Double blind randomized controlled multi-center trial. Study population: Premenopausal women in whom a maximum of 2 symptomatic intramural fibroids between 5 and 12 cm in diameter will be removed. Fibroid types 3, 4, 5, 6 and 2-5 will be included.

Intervention: Three months of Ulipristal 5 mg once daily combined with a single saline injection at the onset of pretreatment (produced as placebo of Leuproreline) or (comparison) 11.25 mg Leuproreline injections at the onset of pretreatment with placebo tablets (once daily) .

Methods: Within 1 month after pre-treatment patients will undergo a laparoscopic myomectomy by experienced surgeons. Operative characteristics will be recorded prospectively. Follow up will be 6 months after surgery mainly for quality of life assessment. A cost utility analysis will be conducted alongside the trial.

Main study parameters/endpoints: Ulipristal is non-inferior to GnRHa in terms of blood loss during surgery when the average difference between the two groups is below 150 ml (standard deviation 250 ml).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both Ulipristal and GnRHa have been registered for this indication. Safety has been tested and no specific risks apply.

Detailed Description

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Conditions

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Fibroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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GnRHa and placebo tablets

11.25 mg Leuproreline injections at the onset of pretreatment with placebo tablets (once daily)

Group Type ACTIVE_COMPARATOR

GnRHa

Intervention Type DRUG

Ulipristal

Three months of Ulipristal 5 mg once daily combined with a single saline injection at the onset of pretreatment (produced as placebo of Leuproreline)

Group Type ACTIVE_COMPARATOR

Ulipristal

Intervention Type DRUG

Control

No pre-treatment prior to laparoscopic myomectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GnRHa

Intervention Type DRUG

Ulipristal

Intervention Type DRUG

Other Intervention Names

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Lucrin Esmya

Eligibility Criteria

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Inclusion Criteria

Women visiting the gynecological outpatient department with symptomatic fibroids will be screened for eligibility. In order to be eligible to participate in this trial, a subject must meet all of the following criteria:

* provide written consent prior to any study related procedures
* pre-menopausal
* a planned resection of a maximum of 2 FIGO (PALM-COEIN classification) type 3, 4, 5, 6 or 2-5 fibroids of \>5 cm
* the(se) fibroid(s) should be between 5 and 12 cm (maximum diameter)
* other fibroids should be small (\<2 cm), not clinically relevant, or not resectable (e.g. difficult position), or type 7 (any size)
* eligible for laparoscopic myomectomy

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this trial:

* Current pregnancy
* (suspicion of) malignancy
* any type 0-2 fibroids smaller than 5 cm
* more than 2 type 3-6 fibroids \> 5 cm that need to be removed (except type 7 fibroids of any size)
* use of any hormonal agents and not willing to discontinue their use
* use of anticoagulants
* coagulopathy
* Use of NSAIDs impacting bleeding before surgery
* Contraindication to laparoscopy procedure or causes of complications (multiple laparotomies, frozen pelvis, severe endometriosis)
* allergy to leuprolide acetate/comparable nonapeptides or Ulipristal
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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I. de Milliano, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wouter Hehenkamp, PhD

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

Locations

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Flevoziekenhuis

Almere Stad, , Netherlands

Site Status RECRUITING

Onze Lieve Vrouwen Gasthuis

Amsterdam, , Netherlands

Site Status RECRUITING

Sint Lucas Andreas Ziekenhuis

Amsterdam, , Netherlands

Site Status RECRUITING

VU medical center

Amsterdam, , Netherlands

Site Status RECRUITING

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status RECRUITING

Spaarne Gasthuis

Haarlem, , Netherlands

Site Status RECRUITING

Radboud University Medical Center

Nijmegen, , Netherlands

Site Status RECRUITING

Maasstad ziekenhuis

Rotterdam, , Netherlands

Site Status RECRUITING

Maxima Medisch Centrum

Veldhoven, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Inge de Milliano, MD

Role: CONTACT

Phone: +31624992776

Email: [email protected]

Facility Contacts

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Marchien van Baal

Role: primary

P Van Kesteren

Role: primary

Andreas Thurkow

Role: primary

Wouter Hehenkamp, PhD

Role: primary

D Schoot

Role: primary

Jonas van de Lande

Role: primary

Sjors Coppus

Role: primary

M Aktas

Role: primary

M Bongers

Role: primary

Other Identifiers

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2014.421

Identifier Type: -

Identifier Source: org_study_id