Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

UNKNOWN

Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy

Lead Sponsor:

Amsterdam UMC, location VUmc

Conditions:

Fibroids

Eligibility:

FEMALE

18+ years

Phase:

PHASE4

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 increas...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2017

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT02288130

Start Date

December 1 2014

End Date

November 1 2017

Last Update

November 3 2016

Active Locations (9)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

1

Flevoziekenhuis

Almere Stad, Netherlands

2

Onze Lieve Vrouwen Gasthuis

Amsterdam, Netherlands

3

Sint Lucas Andreas Ziekenhuis

Amsterdam, Netherlands

4

VU medical center

Amsterdam, Netherlands