Effect of a GnRH Analog on Hepatic Steatosis

Launched by ARISTOTLE UNIVERSITY OF THESSALONIKI · Jul 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called goserelin acetate, which is a type of hormone treatment, on liver conditions related to fat buildup in the liver, particularly in women with endometriosis. The study aims to see how this treatment, which mimics menopause, influences liver health, especially in women who are experiencing metabolic issues after menopause.

To participate in this trial, women of reproductive age who have been diagnosed with endometriosis may be eligible. They should not have other significant liver diseases, a history of certain cancers, or severe kidney problems. Participants will need to give written consent to join the study. Those who qualify can expect to undergo evaluations to monitor their liver health during the trial. It’s important to note that this study is currently recruiting participants, and it aims to provide insights into potential treatments for liver issues linked to hormonal changes.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • women of reproductive age
• • diagnosis of endometriosis. The disease is suspected by patient's individual history (chronic pelvic pain, dyspareunia or/and dysmenorrhea) and the ultrasonographic imaging (chocolate cysts). The diagnosis is confirmed histologically, after laparoscopic surgical treatment and biopsy sampling, which will be interpreted by an independent blinded pathologist.
• • use of contraceptives, which is the first line treatment, is contraindicated or the patient does not consent to receive contraceptives, due to personal preferences.
• • written informed consent to participate to the study
• Exclusion Criteria:
• • mean ethanol consumption \>10 g/day
• • history of other chronic liver disease (e.g., viral hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis and overlap syndromes, drug-induced liver injury, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency)
• • liver cirrhosis
• • any malignancy
• • chronic kidney disease
• • uncontrolled hypothyroidism or hyperthyroidism
• • severe sexual hormone disorders (congenital adrenaline hyperplasia, Down syndrome, Turner syndrome).
• • use of the following medications within a 12-month period before baseline, which are associated with drug-induced liver injury (DILI): interferon, tamoxifen, amiodarone, aloperidin, glucocorticoids, hormone replacement therapy, contraceptives, anabolic steroids, any medication against tuberculosis, epilepsy or viruses, methotrexate, parenteral nutrition
• • use of the following medications within a 12-month period before baseline, which are probably associated with improvement in hepatic steatosis: vitamin E, pioglitazone, insulin, glucagon-like peptide-1 receptor agonists (GLP-1RAs), sodium- glucose co-transporter-2 inhibitors (SGLT-2i), orlistat, ursodeoxycholic acid
• • use of any GnRH agonist or antagonist within a 12-month period before baseline