Evaluating the impact of a GnRH analog on liver fat accumulation
Effect of the Pharmacological Cessation of Menstruation With a GnRH Analog on Hepatic Steatosis in Women With Endometriosis
This study is testing whether a medication that temporarily puts women with endometriosis into menopause can help reduce liver fat and improve liver health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 2 sites (Thessaloniki and 1 other locations) |
| Trial ID | NCT06523530 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of goserelin acetate, a GnRH analog, on hepatic steatosis and fibrosis in women with endometriosis. It aims to understand how this treatment, which induces a temporary menopause, may influence metabolic dysfunction-associated steatotic liver disease (MASLD). The study will include women of reproductive age diagnosed with endometriosis and will assess the relationship between estrogen deficiency and liver health. Participants will receive goserelin acetate via injection to evaluate its impact on liver fat and fibrosis.
Who should consider this trial
Good fit: Ideal candidates are women of reproductive age diagnosed with endometriosis who cannot or choose not to use contraceptives.
Not a fit: Patients with chronic liver diseases, liver cirrhosis, or those consuming excessive alcohol may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing liver disease associated with menopause.
How similar studies have performed: While there is limited clinical data directly linking GnRH analogs to improvements in MASLD, the approach is based on established associations between menopause and liver disease.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Thessaloniki and 1 other locations
- 1st Department of Obstetrics and Gynecology, School of Medicine, Aristotle University of Thessaloniki — Thessaloniki, Greece (Recruiting)
- 424 General Military Hospital — Thessaloniki, Greece (Recruiting)
Study contacts
- Principal investigator: Stergios A Polyzos, MD, PhD — School of Medicine, Aristotle University of Thessaloniki
- Study coordinator: Stergios A Polyzos, MD, PhD
- Email: spolyzos@auth.gr
- Phone: 2310999316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.