Effect of a GnRH Analog on Hepatic Steatosis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAristotle University Of Thessaloniki

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Goserelin Acetate 3.6 mg inj, implant

Treatment groups

62 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Aristotle University Of Thessaloniki

Lead sponsor

424 General Military Hospital

Collaborator