Actively Recruiting
A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease
Led by University Medical Center Groningen · Updated on 2022-11-04
36
Participants Needed
2
Research Sites
278 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Multicenter trial on the effect of the GnRH analogue leuprorelin on the growth of total liver volume in pre-menopausal women with very severe polycystic liver disease who, despite available therapy, experience growth and are heading for liver transplantation.
CONDITIONS
Official Title
A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients
- Diagnosis of polycystic liver disease with more than 10 liver cysts
- Age between 18 and 45 years inclusive
- Very large liver for age defined as upper 10% liver volumes by age group:
- 18-30 years: height adjusted total liver volume > 2.0 L/m
- 30-35 years: height adjusted total liver volume > 2.2 L/m
- 35-40 years: height adjusted total liver volume > 2.5 L/m
- 40-45 years: height adjusted total liver volume > 3.0 L/m
- Availability of at least 1 historical MRI or CT scan between 5 to 1 years before baseline
- Ongoing liver growth confirmed by increase in total liver volume between historical scan and screening MRI
- Use of somatostatin analogue with confirmed liver growth despite treatment, or specific reason not to use somatostatin analogue
- Voluntary written informed consent and ability to complete study questionnaires
You will not qualify if you...
- Post-menopausal status or symptoms indicating upcoming menopause
- Anti Mullerian Hormone (AMH) level below 0.03 ng/ml at screening
- Active desire to have children, pregnancy, or breastfeeding
- Contraindications for leuprorelin, including history of cardiovascular disease, osteoporosis or intolerance
- Planned liver transplantation or surgery within 1.5 years
- Use of hormonal oral contraceptives containing estrogen and/or progesterone
- Contraindications for MRI or inability/unwillingness to undergo MRI
- Kidney transplantation or chronic use of certain immunosuppressive agents
- Severe hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Clinically significant uncontrolled medical condition that risks safety or affects study compliance
- Participation in other interventional studies at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA
Not Yet Recruiting
2
Groningen universitair medical center
Groningen, Netherlands, 9713 GZ
Actively Recruiting
Research Team
R
Ron T Gansevoort
CONTACT
R
Renée Duijzer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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