lipristal versus standard surgical treatment in symptomatic uterine fibroids

Phase 4

Recruiting

Conditions: fibroids
myoma
10038595

Registration Number: NL-OMON52721

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 164

Inclusion Criteria

Women visiting the gynaecological 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, or older

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
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Outcomes with regard to patient:<br /><br>1) Fibroid-specific quality-of-life, measured by the Uterine fibroid<br /><br>symptom-questionnaire (UFS-QOL) symptom severity score (SSS) outcome at 24<br /><br>months after randomization<br /><br><br /><br>Outcomes with regards to costs (using internet medical consumption<br /><br>questionnaires; iMCQ):<br /><br>1) Direct health care costs<br /><br>2) Costs due to loss of productivity (absenteeism from work)<br /><br>3) Patient costs (informal care, other care services paid for by patients<br /><br>themselves)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes with regard to patient:<br /><br><br /><br>1) What is the effect of the intervention on quality of life parameters, such<br /><br>as pain, societal participation and sexual functioning?<br /><br>2) What is the effect of the intervention on fibroid specific complaints such<br /><br>as volume reduction (UPA group); amount of menstrual bleeding (PBAC-score) and<br /><br>Hemoglobin level.<br /><br>3) What is the re-intervention rate in both treatment groups and how many<br /><br>patients choose for an intervention after treatment with UPA??<br /><br>4) What is the effect on patient preference and satisfaction?<br /><br>5) Which complications/side-effects occur?<br /><br>6) What is the effect of UPA-usage on the blood results, regarding liver<br /><br>function?<br /><br>7) Which sub-groups benefit most within the study group (subgroup-analysis)</p><br>