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NCT06523530 | RECRUITING | Metabolic Dysfunction-Associated Steatotic Liver Disease

Effect of a GnRH Analog on Hepatic Steatosis
Sponsor:

Aristotle University Of Thessaloniki

Information provided by (Responsible Party):

Stergios A Polyzos

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.

Condition or disease

Metabolic Dysfunction-Associated Steatotic Liver Disease

Nonalcoholic Fatty Liver

Endometriosis

Intervention/treatment

Goserelin Acetate 3.6 mg inj, implant

Phase

PHASE4

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 general population, whereas the pharmaceutical interventions against it remain limited. Owing to the epidemiologic and pathophysiologic association of MASLD with obesity, type 2 diabetes mellitus, dyslipidemia and arterial hypertension, the diagnostic criteria for MASLD are similar to those of the metabolic syndrome. Menopause has been associated with higher MASLD prevalence, with the lack of estrogen being a very plausible pathogenetic contributor to this liver disease. Other pathogenetic contributors of MASLD, including abdominal obesity, increase in insulin resistance (IR) and dysmetabolism of carbohydrates and lipids, are aggravated after menopause, thus adversely contributing to the pathogenesis of MASLD. Regarding the effect of the lack of estrogen on the liver, most to date data are derived from experimental studies, largely showing a favoring effect on MASLD. Epidemiological studies have also shown menopause as an associate of MASLD. However, existing clinical studies are mostly observational, thereby not being able to show a causative association between menopause and MASLD. Gonadotropin-releasing hormone (GnRH) treatment in disorders such as endometriosis can be regarded as a model of pharmaceutical menopause. More specifically, GnRH analogs, like goserelin acetate, lead to pharmaceutical menopause by suppressing the axis hypothalamus-pituitary-ovaries, thus, causing an iatrogenic, reversible ovarian cessation, which lasts as long as the use of GnRH. The adverse effects of GnRH are generally mild and reversible after their discontinuation. This is a prospective, interventional non-randomized study, which aims to evaluate the effect of goserelin acetate on hepatic steatosis in women with histologically confirmed endometriosis compared with women with endometriosis that will not receive pharmacological treatment post-surgically.

Study Type : INTERVENTIONAL
Estimated Enrollment : 62 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Effect of the Pharmacological Cessation of Menstruation with a GnRH Analog on Hepatic Steatosis in Women with Endometriosis
Actual Study Start Date : 2024-11-26
Estimated Primary Completion Date : 2026-10
Estimated Study Completion Date : 2027-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Effect of a GnRH Analog on Hepatic Steatosis

Location Details

NCT06523530

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Locations

RECRUITING

Greece, Thessaloniki

424 General Military Hospital

Thessaloniki, Thessaloniki, Greece, 56429

RECRUITING

Greece,

1st Department of Obstetrics and Gynecology, School of Medicine, Aristotle University of Thessaloniki

Thessaloniki, Greece, 56403