NL-OMON50796
Recruiting
Phase 2
A GnRH Agonist IN pre-menopausal women STudy to treat severe Polycystic Liver Disease - AGAINST-PLD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cystic livers
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 18
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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)
- •o 18\-30 yr; height adjusted TLV \> 2\.0 L/m
- •o 30\-35 yr; height adjusted TLV \> 2\.2 L/m
- •o 35\-40 yr; height adjusted TLV \> 2\.5 L/m
Exclusion Criteria
- •\- 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\), unexplained vaginal bleeding, or a known
- •intolerance for leuprorelin
- •\- Liver transplantation or liver surgery expected within 1\.5 years, to the
- •discretion of the study doctor
- •\- Use of hormonal oral contra\-conception containing estrogen and/or
Outcomes
Primary Outcomes
Not specified
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