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
17 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
Researchers are studying the effect of the hormone-related drug leuprorelin on liver growth in pre-menopausal women with very severe polycystic liver disease. The trial focuses on women whose liver volume continues to grow despite current treatments and who are at risk of needing a liver transplant. This phase 2, randomized, single-blind study is sponsored by the University Medical Center Groningen and aims to assess liver growth over 36 months. Participants are assigned to one of two groups: the direct start group receives leuprorelin injections for 36 months, beginning with monthly doses for the first three months followed by injections every three months; the delayed start group receives standard care for 18 months before starting leuprorelin for the next 18 months. The study monitors multiple health aspects including liver and kidney growth, hormone levels, bone density, and vital signs throughout the treatment period. Women involved in the trial will undergo regular MRI or CT scans, blood tests, and assessments of physical and mental health over three years. Researchers will track liver size changes as the primary outcome, along with symptoms related to liver disease, menopause, depression, and overall health. Safety is monitored by recording any serious adverse events, and participants provide informed consent before joining the study.
CONDITIONS
Brief 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 based on specific height-adjusted total liver volume thresholds
- Availability of at least one historical MRI or CT scan between 1 and 5 years before baseline
- Ongoing liver growth confirmed by increase in liver volume between historic scan and screening MRI
- Use of somatostatin analogue with confirmed liver growth despite treatment, or specific reasons for not using somatostatin analogues
- 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 measurement less than 0.03 ng/ml at screening
- Desire to have children, pregnancy, or breastfeeding
- Contraindications for leuprorelin including cardiovascular disease, osteoporosis, or intolerance
- Expected liver transplantation or surgery within 1.5 years
- Use of hormonal oral contraceptives containing estrogen or progesterone
- Contraindications for MRI or inability/unwillingness to undergo MRI
- Kidney transplantation or chronic use of immunosuppressive agents for other reasons
- Severe hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Clinically significant uncontrolled medical conditions that risk patient safety or affect study compliance
- Participation in other interventional studies concurrently
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months depending on group assignment
Participants receive monthly injections of leuprorelin for the first 3 months, followed by injections every 3 months. The direct start group receives treatment for 36 months. The delayed start group receives standard care for 18 months before starting 18 months of treatment.
Monthly visits for the first 3 months, then visits every 3 months thereafter
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
R
Renée Duijzer
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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