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RECRUITINGPhase 4INTERVENTIONAL

Effect of a GnRH Analog on Hepatic Steatosis

Effect of the Pharmacological Cessation of Menstruation With a GnRH Analog on Hepatic Steatosis in Women With Endometriosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form to participate to the study Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Goserelin Acetate 3.6 mg inj, implant

3.6 mg (1ml) administered subcutaneously once every month for 6 months (totally 6 injections)

Locations (2)

1st Department of Obstetrics and Gynecology, School of Medicine, Aristotle University of Thessaloniki
Thessaloniki, Greece
424 General Military Hospital
Thessaloniki, Greece