Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy

Fibroids Clinical Trial

— MYOMEX  

Official title:

Ulipristal Versus Gonadotropin-releasing Hormone Agonists Prior to Laparoscopic Myomectomy: a Double Blind Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02288130
• Other study ID #: 2014.421
• Status: Recruiting
• Phase: Phase 4
• First received: November 6, 2014
• Last updated: November 2, 2016
• Start date: December 2014
• Est. completion date: November 2017

Study information

• Verified date: November 2016
• Source: VU University Medical Center
• Contact: Inge de Milliano, MD
• Phone: +31624992776
• Email: i.demilliano[@]vumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibroids

Intervention

Drug:
• GnRHa

• Ulipristal

Locations

Country	Name	City	State
Netherlands	Flevoziekenhuis	Almere
Netherlands	Onze Lieve Vrouwen Gasthuis	Amsterdam
Netherlands	Sint Lucas Andreas Ziekenhuis	Amsterdam
Netherlands	VU medical center	Amsterdam
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Spaarne Gasthuis	Haarlem
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	Maasstad ziekenhuis	Rotterdam
Netherlands	Maxima Medisch Centrum	Veldhoven

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss during surgery	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)	Reported directly after surgery	No