Inclusion criteria | Â |
---|---|
 Female |  |
 Diagnosis of PLD (presence of > 10 cysts) |  |
 Age 18–45 (inclusive) years |  |
 Very large liver for age: |  |
  18–30 y hTLV > 2.0 L/m |  |
  30–35 y hTLV > 2.2 L/m |  |
  25–40 y hTLV > 2.5 L/m |  |
  40–45 y hTLV > 3.0 L/m |  |
 1 historical MRI or CT scan of the liver available, made 5-1 y before baseline |  |
 Ongoing liver growth, confirmed using the historical scan and MRI scan at screening |  |
 Use of somatostatin analogues OR a reason not to use them (e.g. tried in de past but stopped because of side effects, not effective, no acces, patient does not want to) |  |
 Voluntary written informed consent |  |
Exclusion criteria | Â |
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 Post menopausal status or (vasomotor) symptoms indicating upcoming menopause |  |
 AMH < 0.03 ng/ml at screening |  |
 Active desire to have children, pregnancy or breast-feeding |  |
 Contra-indications for leuprorelin, such as cardiovascular disease or osteoporosis |  |
 Liver transplantation expected within 1.5 years |  |
 Use of oral estrogen or progesterone containing medication |  |
 Contra-indications for MRI |  |
 Chronic use of immunosupressive agents |  |
 Severe hypertension (systolic pressure ≥ 160 and/or diastolic pressure ≥ 100 mmHg) |  |
 Clinically significant uncontrolled medical condition that, in the opinion of the investigator, would put the safety of the patient at risk though participation, or which would affect efficacy or safety analysis, such as, but not limited to, recurrent cholangitis, recurrent ascites, hepato-venous outflow obstruction, (history of) depression |  |
 Participation in other interventional studies at the same time |  |
Exclusion criteria related to the historical MRI/CT scan | Â |
---|---|
 Start or stop of liver volume reducing therapy (medication e.g. somatostain analogues or surgical interventions) between the historical scan and screening |  |
 Historical scan is performed < 3 months after start or stop of volume reducing therapy (either a somatostatin analogue or surgical treatments) |  |