lipristal versus surgery for symptomatic uterine fibroids

Phase 1

• Conditions: terine fibroids are very common during reproductive years in women. Minimally invasive treatments are emerging. Myomectomy is the gold standard, preferably laparoscpically, because it removes the fibroids entirely. Ulipristal, a selective progesterone receptor modulator, was introduced in 2012 as a new revolutionary (long-term) treatment for symptomatic uterine fibroids. It claims to make invasive treatment unnecessary.; MedDRA version: 21.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2017-005120-16-NL
• Lead Sponsor: Amsterdam UMC, Location VUmc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-20
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 179

Inclusion Criteria

Women visiting the gynaecological outpatient clinic 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:
-Symptomatic fibroids warranting surgical treatment, either hysterectomy, myomectomy or uterine artery embolization
-Conservative treatment failed or is undesired
-Pre-menopausal
->18 years of age

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 179
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Asymptomatic fibroids
-Current pregnancy or unwillingness to use contraception
-Suspicion of malignancy
-Current use of ulipristal
-Contra-indication for the use of ulipristal
oHistory of, or present liver disease or hepatic impairment;
oTransaminases (alanine transaminase (ALT) or aspartate aminotransferase (AST) and/or total bilirubin exceeds 2 times the upper limit of
normal (performed within a month prior to inclusion).
oMedication that interacts with ulipristal:
?Moderate CYP3A4 inhibitors (e.g. erythromycin, grapefruit juice, verapamil)
?Potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, nefazodone, itraconazole, clarithromycine)
?Potent CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, St. John’s wort, efavirenz)
-Not willing or able to give written informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified