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van CCT (UK)

van CCT (UK)


- candidate number28296
- NTR NumberNTR6860
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-dec-2017
- Secondary IDsABR-kenmerk NL62638.029.17
- Public TitleMYOMEX-2
- Scientific TitleUlipristal versus standard surgical treatment in symptomatic uterine fibroids
- hypothesisUlipristal acetate (UPA) is non-inferior to surgical treatment measured by UFS-QOL (Symptom Severity) scores.
- Healt Condition(s) or Problem(s) studiedSymptomatic uterine fibroids, Symptomatic uterine fibroids
- Inclusion criteriaWomen visiting the gynecological 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
- Exclusion criteriaA 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
- Not willing or able to give written informed consent
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2018
- planned closingdate
- Target number of participants146
- InterventionsPatients will be randomly assigned to two groups. One group will receive no additional medicinal treatment and will undergo standard surgical treatment (hysterectomy, myomectomy or uterine artery embolization). The other group will receive the medicinal treatment (daily one 5 mg tablet of UPA during 12 weeks), followed by a drug-free interval of 2 months. This course will be repeated for a maximum of 4 times. In total patients will be ‘on treatment’ for 18 months.
- Primary outcomePrimary outcomes with regard to patient:
1) Fibroid-specific quality-of-life, measured by the Uterine Fibroid Symptom-questionnaire (UFS-QOL) symptom severity score (SSS)outcome at 24 months after randomization.

Primary outcomes with regard to costs (using internet medical consumption questionnaires; iMCQ):
1) Direct healthcare costs
2) Costs due to loss of productivity (absenteeism from work)
3) Patient costs (informal care, other care services paid for by patients themselves)
- Secondary outcomeSecondary outcomes with regard to patient:
1) What is the effect of the intervention on Quality-of-Life (symptom-severity-score), pain, societal participation and sexual functioning?
2) What is the re-intervention rate in both treatment groups?
3) What is the effect on patient preference and satisfaction?
4) Which complications/side-effects occur?
5) Which sub-groups benefit most within the study group (subgroup-analysis)
- TimepointsBaseline, with
24 months of follow-up
- Trial web
- statusplanned
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryUterine fibroids are very common during reproductive years in women. Ulipristal acetate (UPA), a selective progesterone receptor modulator, was introduced in 2012 as a new treatment option for symptomatic uterine fibroids. UPA induces a volume reduction and Uterine Fibroid Symptoms questionnaires filled in by the patients revealed a improvement in quality-of- life and reduction in symptom scores. UPA was launched as a revolutionary medication for fibroids, claiming to make invasive treatment unnecessary. However, UPA is quite costly and has never been compared to other treatment modalities. In this study we will compare UPA with standard surgical treatment (hysterectomy, myomectomy or uterine artery embolization), to study the effect in quality of life, symptom severity scores and health- care costs (primary outcomes) between both treatments. This is a multicenter trial which will be performed in the Netherlands.
- Main changes (audit trail)
- RECORD4-dec-2017 - 4-jan-2018

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