Early access
Sign in
Taking peoplePhase 4

Ulipristal compared with surgery for uterine fibroids that cause symptoms

Compares ulipristal with surgery in adults who have symptomatic uterine fibroids.

Key facts

Who runs it
Amsterdam UMC Stichting
Where
Netherlands12 sites in 1 countryChoose a country to see its sites
Registry title
Ulipristal versus surgery for symptomatic uterine fibroids
Status
Recruiting
Phase
Phase 4
People taking part
164 people, planned
Started
2 Dec 2024
Expected to end
31 Dec 2026
Type of study
Interventional
Record updated
2 December 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women before menopause with uterine fibroids that cause symptoms and need surgery. It compares ulipristal with standard surgery.

Age
>18 years of age (record lists 18 Years to 64 Years).
Sex
Women only.
Disease stage
Fibroids that cause symptoms and need surgery: hysterectomy (removal of the womb), myomectomy (removal of fibroids) or uterine artery embolization (blocking the blood supply to the fibroids). Women must not have gone through menopause yet.
Earlier treatment
Non-surgical treatment did not work, or the woman does not want it. People currently using ulipristal cannot join.

Main reasons for not taking part

  • Fibroids without symptoms.
  • Being pregnant now, or not willing to use birth control.
  • Suspected cancer.
  • Past or present liver disease, or ALT, AST or total bilirubin above 2 times the upper limit of normal.
  • Taking medicines that interact with ulipristal, such as some CYP3A4 inhibitors or inducers (for example erythromycin, grapefruit juice, ketoconazole, rifampicin, St. John's wort).

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

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

Who cannot take part

  • Suspicion of malignancy
  • 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)
  • Asymptomatic fibroids
  • Current pregnancy or unwillingness to use contraception
  • Current use of ulipristal
  • Not willing or able to give written informed consent

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 64 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Fibroid-specific quality-of-life, measured by the Uterine Fibroid Symptom-questionnaire (UFS-QOL) and symptom severity scores. Outcome at 24 months after randomization

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Ulipristal versus standard surgical treatment in symptomatic uterine fibroids
Plain-language title
Ulipristal compared with surgery for uterine fibroids that cause symptomsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Fit questions
Built from 2024-512602-26-00, who can take part
Record updated
2 December 2024