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RECRUITING
NCT05478083
PHASE2

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

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2022-06-01

Completion Date

2027-10-01

Last Updated

2022-11-04

Healthy Volunteers

No

Interventions

DRUG

Leuprorelin

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.

Locations (2)

Radboudumc

Nijmegen, Gelderland, Netherlands

Groningen universitair medical center

Groningen, Netherlands