Status:
RECRUITING
Effect of a GnRH Analog on Hepatic Steatosis
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborating Sponsors:
424 General Military Hospital
Conditions:
Metabolic Dysfunction-Associated Steatotic Liver Disease
Nonalcoholic Fatty Liver
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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 endo...
Detailed Description
The prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD), which until recently was known as nonalcoholic fatty liver disease (NAFLD), has risen to 30% of the global adult gen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06523530
Start Date
November 26 2024
End Date
April 1 2027
Last Update
December 13 2024
Active Locations (2)
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1
424 General Military Hospital
Thessaloniki, Thessaloniki, Greece, 56429
2
1st Department of Obstetrics and Gynecology, School of Medicine, Aristotle University of Thessaloniki
Thessaloniki, Greece, 56403