No registrations found.
ID
Source
Brief title
Health condition
symptomatic uterine fibroids
Symptomatische uterine myomen
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary 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 outcome
Secondary outcomes with regard to patient:
1) What is the effect of the intervention on Quality-of-Life (parameters), 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)
Background summary
Uterine 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.
Study objective
Ulipristal acetate (UPA) is non-inferior to surgical treatment measured by UFS-QOL (Symptom Severity) scores.
Study design
Baseline, with
24 months of follow-up
Intervention
Patients are randomly assigned in a 2:1 ratio to two groups. One group (N=60) will receive no additional medicinal treatment and will undergo standard surgical treatment (hysterectomy, myomectomy or uterine artery embolization). The other group (N=119) will receive the medicinal treatment (daily one 5 mg tablet of UPA during 12 weeks), followed by a drug-free interval of 2 months. In total, the treatment course will be administered three times, or – when desired and well tolerated- a maximum of four times. In total patients will be ‘on treatment’ for 13-18 months (depending on the amount of treatment courses).
De Boelelaan 1117 (ZKH 8B87)
Amsterdam 1081 HV
The Netherlands
+31651 742621
m.middelkoop@vumc.nl
De Boelelaan 1117 (ZKH 8B87)
Amsterdam 1081 HV
The Netherlands
+31651 742621
m.middelkoop@vumc.nl
Inclusion criteria
Women 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 criteria
A 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6690 |
| NTR-old | NTR6860 |
| Other | NL62638.029.17 : ABR-kenmerk |