Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy

NCT02288130 | Unknown Phase 4

• 1 other identifier: 2014.421
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

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.

Conditions

Fibroids

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

GnRHa and placebo tablets

ACTIVE COMPARATOR

11.25 mg Leuproreline injections at the onset of pretreatment with placebo tablets (once daily)

Drug: GnRHa

Ulipristal

ACTIVE COMPARATOR

Three months of Ulipristal 5 mg once daily combined with a single saline injection at the onset of pretreatment (produced as placebo of Leuproreline)

Drug: Ulipristal

Control

NO INTERVENTION

No pre-treatment prior to laparoscopic myomectomy

Interventions

GnRHa DRUG

Also known as: Lucrin

GnRHa and placebo tablets

Ulipristal DRUG

Also known as: Esmya

Ulipristal

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (9)

Flevoziekenhuis

Almere Stad, Netherlands

RECRUITING

Onze Lieve Vrouwen Gasthuis

Amsterdam, Netherlands

RECRUITING

Sint Lucas Andreas Ziekenhuis

Amsterdam, Netherlands

RECRUITING

VU medical center

Amsterdam, Netherlands

RECRUITING

Catharina Ziekenhuis

Eindhoven, Netherlands

RECRUITING

Spaarne Gasthuis

Haarlem, Netherlands

RECRUITING

Radboud University Medical Center

Nijmegen, Netherlands

RECRUITING

Maasstad ziekenhuis

Rotterdam, Netherlands

RECRUITING

Maxima Medisch Centrum

Veldhoven, Netherlands

RECRUITING

MeSH Terms

Conditions

Leiomyoma

Interventions

Leuprolide; ulipristal; ulipristal acetate

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Wouter Hehenkamp, PhD

  Amsterdam UMC, location VUmc

  STUDY CHAIR

Central Study Contacts

Inge de Milliano, MD

CONTACT

+31624992776; i.demilliano@vumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 11, 2014
• Study Start: December 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 3, 2016

Record last verified: 2016-11

Locations

NL (9)