Clinical trial NCT02288130: Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy
Official title: Ulipristal Versus Gonadotropin-releasing Hormone Agonists Prior to Laparoscopic Myomectomy: a Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fibroids
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood loss during surgery
timeFrame: Reported directly after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwen Gasthuis
city: Amsterdam
country: Netherlands
facility: Sint Lucas Andreas Ziekenhuis
city: Amsterdam
country: Netherlands
facility: VU medical center
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Rotterdam
country: Netherlands
facility: Maasstad ziekenhuis
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Wouter Hehenkamp, PhD
role: STUDY_CHAIR
References: