A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity Medical Center Groningen
About this trial
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.
Eligibility criteria
Qualifiers
Female patients
Diagnosis of polycystic liver disease defined as the presence of more than 10 liver cysts
Age between 18 to 45 (inclusive) years;
Very large liver for age, defined as the upper 10% of liver volumes in specific age categories (based on a retrospective polycystic liver disease registry, n=1.600 patients)
Disqualifiers
Anti Mullerian Hormone (AMH) measurement at screening visit <0.03 ng/ml.
Active desire to have children, pregnancy or breast-feeding
Contra-indications for leuprorelin, such as history of cardiovascular disease, history of osteoporosis or osteoporosis determined by DEXA-scan at screening (T score ≤ - 2.5), or a known intolerance for leuprorelin
Liver transplantation or liver surgery expected within 1.5 years, to the discretion of the study doctor
Trial design
Treatments tested in this trial
- Leuprorelin
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Medical Center Groningen
Lead sponsor
Radboud University Medical Center
Collaborator
Source ClinicalTrials.gov