Ulipristal versus surgery for symptomatic uterine fibroids

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC Stichting

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

2 Dec 2024 → ongoing

Decision date (initial)

2024-12-02

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

ZonMW

External identifiers

EU CT number

2024-512602-26-00

EudraCT number

2017-005120-16

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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

Conditions and MedDRA coding

Uterine fibroids

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Symptomatic fibroids warranting surgical treatment, either hysterectomy, myomectomy or uterine artery embolization
2. Conservative treatment failed or is undesired
3. Pre-menopausal
4. >18 years of age

Exclusion criteria 6

1. Asymptomatic fibroids
2. Current pregnancy or unwillingness to use contraception
3. Suspicion of malignancy
4. Current use of ulipristal
5. 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)
6. Not willing or able to give written informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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.
2. 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)

Secondary endpoints 7

1. What is the effect of the intervention on quality of life parameters, such as pain, societal participation and sexual functioning?
2. 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.
3. What is the re-intervention rate in both treatment groups and how many patients choose for an intervention after treatment with UPA?
4. What is the effect on patient preference and satisfaction?
5. Which complications/side-effects occur?
6. What is the effect of UPA-usage on the blood results, regarding liver function?
7. Which sub-groups benefit most within the study group (subgroup-analysis)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC Stichting

Sponsor organisation

Amsterdam UMC Stichting

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC Stichting

Contact name

Dr. W. Hehenkamp

Public contact point

Organisation

Amsterdam UMC Stichting

Contact name

Dr. W. Hehenkamp

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications