Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy (MYOMEX)
Fibroids
About this trial
This is an interventional treatment trial for Fibroids
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
Sites / Locations
- FlevoziekenhuisRecruiting
- Onze Lieve Vrouwen GasthuisRecruiting
- Sint Lucas Andreas ZiekenhuisRecruiting
- VU medical centerRecruiting
- Catharina ZiekenhuisRecruiting
- Spaarne GasthuisRecruiting
- Radboud University Medical CenterRecruiting
- Maasstad ziekenhuisRecruiting
- Maxima Medisch CentrumRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
No Intervention
GnRHa and placebo tablets
Ulipristal
Control
11.25 mg Leuproreline injections at the onset of pretreatment with placebo tablets (once daily)
Three months of Ulipristal 5 mg once daily combined with a single saline injection at the onset of pretreatment (produced as placebo of Leuproreline)
No pre-treatment prior to laparoscopic myomectomy