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Recruiting Phase 4 NCT06523530

Effect of a GnRH Analog on Hepatic Steatosis

Trial Parameters

Condition Metabolic Dysfunction-Associated Steatotic Liver Disease
Sponsor Aristotle University Of Thessaloniki
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 62
Sex FEMALE
Min Age 18 Years
Max Age 45 Years
Start Date 2024-11-26
Completion 2027-04
Interventions
Goserelin Acetate 3.6 mg inj, implant

Brief Summary

Menopause increases the risk of metabolic dysfunction-associated steatotic liver disease (MASLD), possibly owing to the abrupt lack of estrogen. Gonadotropin-releasing hormone (GnRH) treatment in endometriosis is regarded as a model of pharmaceutical menopause. Thus, the effect of goserelin acetate, a GnRH analog that results in transient menopause, on hepatic steatosis and fibrosis will be evaluated in this study.

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

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