Effect of a GnRH Analog on Hepatic Steatosis

What this trial studies

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.

Conditions in scope

• Metabolic Dysfunction-Associated Steatotic Liver Disease
• Nonalcoholic Fatty Liver
• Endometriosis

Interventions

• Goserelin Acetate 3.6 mg inj, implant (Drug) — 3.6 mg (1ml) administered subcutaneously once every month for 6 months (totally 6 injections)

Who can join

Women only · Ages 18 Years to 45 Years

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: PHASE4
• Start date: 2024-11-26
• Primary completion: 2027-04
• Last update posted: 2026-02-03
• First posted: 2024-07-26

Sponsor & contact

Lead sponsor: Aristotle University Of Thessaloniki (Other)

Collaborators: 424 General Military Hospital

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Hepatic steatosis (6 months)
  Ultrasound-Guided Attenuation Parameter (UGAP) measured on an ultrasound machine GE Logiq E10s. Between-within group interactions in UGAP UGAP is a non-invasive index based on the attenuation quantification of the ultrasound beam through the hepatic parenchyma, thus used for hepatic steatosis quantification. Cut-off values of ≥ 0.53 dB/cm/MHz, ≥ 0.60 dB/cm/MHz, and ≥ 0.65 dB/cm/MHz have been proposed for the diagnosis…
• Hepatic fibrosis (6 months)
  Liver stiffness (LS) measured with 2D Shear Wave Elastography (2D SWE) on an ultrasound machine GE Logiq E10s. Between-within group interactions in LS 2D SWE is a non-invasive tool measuring the hepatic parenchyma stiffness, thus indirectly suggesting fibrosis stage (F). Cut-offs values of \<8.27 kPa, 8.27-9.39 kPa, 9.40-11.88 kPa and ≥11.88 kPa have been proposed for F0-F1, F2, F3, and…

Related ClearedRx care

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