A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease

Exclusion Criteria10

• Post-menopausal status or (vasomotor) symptoms indicating upcoming menopause
• 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
• Contra-indications for MRI assessments (such as implants) or not able or willing to undergo MRI scan for other reasons (e.g. claustrophobia, profound obesity)
• Kidney transplantation or chronic use of immunosuppressive agents (such as cyclosporine, mycophenolic acid, tacrolimus but not prednisolone) for other indications
• Severe hypertension, defined as a systolic blood pressure \>160 mmHg and/or diastolic blood pressure \> 100 mm Hg.
• Clinically significant, uncontrolled medical condition that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which would affect the efficacy of safety analysis if the condition exacerbated during the study, or that may significantly interfere with study compliance, such as, but not restricted to, recurrent cholangitis, recurrent ascites or hepato-venous outflow obstruction, (history of) depression
• Participation in other interventional studies at the same time.