Uterine fibroids are very common during reproductive years in women. Minimally invasive treatments are emerging. Myomectomy is the gold standard which removes the fibroids entirely, preferably laparoscopically because of a faster recovery and cosmetical benefits, although the succes of a laparoscopic approach is dependent on the size of the fibroid(s) and the difficulty of dissection. MedDRA version: 17.0 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 1000000
Conditions
Interventions
Trade Name: Esmya
Pharmaceutical Form: Tablet
INN or Proposed INN: ulipristalacetate
CAS Number: 126784-99-4
Other descriptive name: ULIPRISTAL ACETATE
Concentration unit: mg milligram(s)
Concentratio
Sponsors
VU university medical center
Eligibility
Sex/Gender
All
Inclusion 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 (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this trial: ? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 and side effects (hot flushes) for the patient. 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. In this study Ulipristal will be compared to the gold standard: GnRH analogues in order to pre-treat fibroids that will be removed by laparoscopic myomectomy.;Secondary Objective: Furthermore the following outcomes will be investigated: volume reduction, surgical time, surgical ease, complications, quality of life, satisfaction and costs. ;Primary end point(s): In this study it will be investigated if Ulipristal is non-inferior to GnRH in terms of intra-operative blood-loss (primary outcome).;Timepoint(s) of evaluation of this end point: This endpoint will be reached when the last patient is operated on. This will be around 4 months after inclusion of the last patient, since pre-treatment takes 3 months, after which surgery will take place within a month. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Furthermore the following outcomes will be investigated: volume reduction, surgical time, surgical ease, complications, quality of life, satisfaction and costs.;Timepoint(s) of evaluation of this end point: The last endpoint will be obtained with the last questionnaire 6 months after treatment. | — |
Countries
Netherlands
Contacts
Public ContactDept of gynaecology
VU university medical center
Outcome results
None listed