Effect of a GnRH Analog on Hepatic Steatosis

Last updated: February 1, 2026
Sponsor: Aristotle University Of Thessaloniki
Overall Status: Active - Recruiting

Phase

4

Condition

Liver Disease

Endometriosis

Hepatic Fibrosis

Treatment

Goserelin Acetate 3.6 mg inj, implant

Clinical Study ID

NCT06523530
5221
  • Ages 18-45
  • Female

Study 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

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 ultrasonographicimaging (chocolate cysts). The diagnosis is confirmed histologically, afterlaparoscopic surgical treatment and biopsy sampling, which will be interpreted by anindependent blinded pathologist.

  • use of contraceptives, which is the first line treatment, is contraindicated or thepatient does not consent to receive contraceptives, due to personal preferences.

  • written informed consent to participate to the study

Exclusion

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-antitrypsindeficiency)

  • 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 areassociated with drug-induced liver injury (DILI): interferon, tamoxifen, amiodarone,aloperidin, glucocorticoids, hormone replacement therapy, contraceptives, anabolicsteroids, any medication against tuberculosis, epilepsy or viruses, methotrexate,parenteral nutrition

  • use of the following medications within a 12-month period before baseline, which areprobably associated with improvement in hepatic steatosis: vitamin E, pioglitazone,insulin, glucagon-like peptide-1 receptor agonists (GLP-1RAs), sodium- glucoseco-transporter-2 inhibitors (SGLT-2i), orlistat, ursodeoxycholic acid

  • use of any GnRH agonist or antagonist within a 12-month period before baseline

Study Design

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: Goserelin Acetate 3.6 mg inj, implant
Phase: 4
Study Start date:
November 26, 2024
Estimated Completion Date:
October 31, 2027

Study 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.

Connect with a study center

  • 424 General Military Hospital

    Thessaloniki, 56429
    Greece

    Site Not Available

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

    Thessaloniki 734077, 56403
    Greece

    Active - Recruiting

  • 424 General Military Hospital

    Thessaloniki 734077, 56429
    Greece

    Active - Recruiting

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

    Thessaloníki, 56403
    Greece

    Site Not Available

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