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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
Treatment consist of leuprorelin 3.75 mg once monthly for the first 3 months followed by 3-monthly injections of 11.25 mg. The direct start group will use leuprorelin for 36 months. The delayed start group will use standard of care in the first 18 months.
Radboudumc
Nijmegen, Gelderland, Netherlands
NOT_YET_RECRUITINGGroningen universitair medical center
Groningen, Netherlands
RECRUITINGLiver growth
Liver volumes (in % per year) measured in the MRI at screening, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months
Polycystic liver disease related complaints
PLD related complaints assessed by the Polycystic liver disease-Questionnaire at baseline, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months
Menopause related complaints
Menopause related complaints by using the validated MENQOL questionnaire at baseline, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months
Patient reported mental health
Quality of life and as subset mental health will be measured by the validated RAND SF-36 questionnaires at baseline, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months
Patient reported physical health
Quality of life and as subset physical health will be measured by the validated RAND SF-36 questionnaires at baseline, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months
Kidney growth
Kidney volumes (in % per year) measured in the MRI at screening, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months
Sex hormone levels
Anti Muller Hormone will be assessed at screening. Other Extensive laboratory includes estradiol, progesterone, AMH, FSH, LH levels at baseline, 6 months after start therapy and after 18 and 36 months.
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Time frame: 36 months
Bone density
Bone density measured by a DEXA scan at screening, 18 months and 36 months.
Time frame: 36 months
Renal function
eGFR measurements and 24h urine analyisis (in ADPKD patients only) at baseline, 6 months, 18 months, 24 months and 36 months time
Time frame: 36 months
Bloodpressure
Manual blood pressure measurements in millimetres of mercury (measure 3 times with 2 minutes in between) at screening, baseline, 3 months, 6 months, 12 months, 18months, 21 months, 24 months, 30 months and 36 months .
Time frame: 36 months
Heart rate
Heart rate in beats per minute (measure 3 times with 2 minutes in between) measured at screening, baseline, 3 months, 6 months, 12 months, 18months, 21 months, 24 months, 30 months and 36 months .
Time frame: 36 months
Weight
Body weight in kilograms measured at screening, baseline, 3 months, 6 months, 12 months, 18months, 21 months, 24 months, 30 months and 36 months .
Time frame: 36 months
Upper-arm-circumference
Upper-arm-circumference in centimeters of the non-dominant arm measured at screening, baseline, 3 months, 6 months, 12 months, 18months, 21 months, 24 months, 30 months and 36 months.
Time frame: 36 months
Abdominal circumference
Abdominal circumference in centimeters (measured at the level of the umbilicus) measured at screening, baseline, 3 months, 6 months, 12 months, 18months, 21 months, 24 months, 30 months and 36 months . At screening, length will be collected to calculate Body Mass Index.
Time frame: 36 months
Length
At screening length in centimeters will be collected.
Time frame: 1 month
The number of participants experciencing a (serious) adverse events
During each physical or telephone contact, the adverse effects are queried and registered in accordance with national protocol
Time frame: 36 months
Symptoms of depression
Symptoms of depression measured by the validated BD-II questionnaires at baseline, 6 months, 18 months, 24 months and 36 months
Time frame: 36 months