Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy
Status:
Unknown status
Trial end date:
2017-11-01
Target enrollment:
Participant gender:
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.