BridgeMD
Ulipristal versus surgery for symptomatic uterine fibroids
EU CTIS ID: 2024-512602-26-00
What this study is testing
Fibroid-specific quality-of-life, measured by the Uterine Fibroid Symptom-questionnaire (UFS-QOL) and symptom severity scores. Outcome at 24 months after randomization
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Symptomatic fibroids warranting surgical treatment, either hysterectomy, myomectomy or uterine artery embolization
- Conservative treatment failed or is undesired
- Pre-menopausal
- >18 years of age
You likely can't join if
- Asymptomatic fibroids
- Current pregnancy or unwillingness to use contraception
- Suspicion of malignancy
- Current use of ulipristal
- 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, clarithromycine) Potent CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort, efavirenz)
- Not willing or able to give written informed consent
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.