ULIPRISTAL ACETATE for Uterine fibroids

Inclusion criteria

• {"criterion_text":"-Symptomatic fibroids warranting surgical treatment, either hysterectomy, myomectomy or uterine artery embolization"}
• {"criterion_text":"-Conservative treatment failed or is undesired"}
• {"criterion_text":"-Pre-menopausal"}
• {"criterion_text":"->18 years of age"}

Exclusion criteria

• {"criterion_text":"-Asymptomatic fibroids"}
• {"criterion_text":"-Current pregnancy or unwillingness to use contraception"}
• {"criterion_text":"-Suspicion of malignancy"}
• {"criterion_text":"-Current use of ulipristal"}
• {"criterion_text":"-Contra-indication for the use of ulipristal o History of, or present liver disease or hepatic impairment; o Transaminases (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). o Medication that interacts with ulipristal:  Moderate CYP3A4 inhibitors (e.g. erythromycin, grapefruit juice, verapamil)  Potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, nefazodone, itraconazole, claritromycine)  Potent CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort, efavirenz)"}
• {"criterion_text":"-Not willing or able to give written informed consent"}

Primary endpoints

• {"endpoint_text":"-Primary study parameter with regard to the patient is the uterine fibroid symptom quality of life questionnaire (UFS-QOL), generating a symptom severity score (SSS) at 24 months after randomization.","definition_or_measurement_approach":"Measured using the Uterine Fibroid Symptom-questionnaire (UFS-QOL) producing a Symptom Severity Score (SSS) assessed at 24 months after randomization."}
• {"endpoint_text":"-The other primary outcome relates to costs, with a breakdown to: Direct health care costs; Costs due to loss of productivity (absenteeism from work); Patient costs (informal care, other care services paid for by patients themselves)","definition_or_measurement_approach":"Costs broken down into direct health care costs, productivity loss (absenteeism) and patient costs; measurement referenced to internet medical consumption questionnaires (iMCQ) as per translations."}

Secondary endpoints

• {"endpoint_text":"-What is the effect of the intervention on quality of life parameters, such as pain, societal participation and sexual functioning?","definition_or_measurement_approach":""}
• {"endpoint_text":"-What is the effect of the intervention on fibroid specific complaints such as volume reduction (UPA group); amount of menstrual bleeding (PBAC-score) and Hemoglobin level.","definition_or_measurement_approach":"Includes measurement of fibroid volume reduction (UPA group), menstrual blood loss via PBAC score, and haemoglobin level."}
• {"endpoint_text":"-What is the re-intervention rate in both treatment groups and how many patients choose for an intervention after treatment with UPA?","definition_or_measurement_approach":"Re-intervention rates and counts of patients choosing subsequent intervention after UPA will be recorded."}
• {"endpoint_text":"-What is the effect on patient preference and satisfaction?","definition_or_measurement_approach":""}
• {"endpoint_text":"-Which complications/side-effects occur?","definition_or_measurement_approach":"Collection and reporting of complications and adverse events."}
• {"endpoint_text":"-What is the effect of UPA-usage on the blood results, regarding liver function?","definition_or_measurement_approach":"Monitoring of liver function tests (e.g. ALT, AST, total bilirubin) as part of safety assessments."}
• {"endpoint_text":"-Which sub-groups benefit most within the study group (subgroup-analysis)","definition_or_measurement_approach":"Planned subgroup analyses to identify subgroups with greatest benefit."}

Netherlands

Earliest CTIS Part Ii Submission Date

14-08-2024

Latest Decision Or Authorization Date

02-12-2024

Processing Time Days

110

Number Of Sites

12

Number Of Participants

164

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"ZonMW","duties_or_roles":"Monetary support / funding","organisation_type":""}
• {"country":"","full_name":"GEDEON RICHTER PLC.","duties_or_roles":"Manufacturer/marketing authorisation holder for Esmya (product listed in trial documents)","organisation_type":""}