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

ConditionsPolycystic Liver DiseaseAutosomal Dominant Polycystic Kidney
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Leuprorelin

    Drug

    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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Direct startActive comparator 1 intervention
Group B: Delayed startOther 1 intervention

Trial outcomes

Primary outcomes

1

Liver 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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Groningen

Lead sponsor

Radboud University Medical Center

Collaborator

Source ClinicalTrials.gov
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