Study of Leuprorelin Treatment in Pre-menopausal Women Aged 18 to 45 With Severe Polycystic Liver Disease

What this Trial Is About

Researchers are studying the effect of the hormone-related drug leuprorelin on liver growth in pre-menopausal women with very severe polycystic liver disease. The trial focuses on women whose liver volume continues to grow despite current treatments and who are at risk of needing a liver transplant. This phase 2, randomized, single-blind study is sponsored by the University Medical Center Groningen and aims to assess liver growth over 36 months. Participants are assigned to one of two groups the direct start group receives leuprorelin injections for 36 months, beginning with monthly doses for the first three months followed by injections every three months the delayed start group receives standard care for 18 months before starting leuprorelin for the next 18 months. The study monitors multiple health aspects including liver and kidney growth, hormone levels, bone density, and vital signs throughout the treatment period. Women involved in the trial will undergo regular MRI or CT scans, blood tests, and assessments of physical and mental health over three years. Researchers will track liver size changes as the primary outcome, along with symptoms related to liver disease, menopause, depression, and overall health. Safety is monitored by recording any serious adverse events, and participants provide informed consent before joining the study.

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