NCT06523530Active, not recruitingPhase 4
Effect of a GnRH Analog on Hepatic Steatosis
Effect of the Pharmacological Cessation of Menstruation With a GnRH Analog on Hepatic Steatosis in Women With Endometriosis
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 10 Jul 2024
- Start date
- 26 Nov 2024
- Primary completion date
- Apr 2027
- Lead sponsor
- Aristotle University Of Thessaloniki
- NCT number
- NCT06523530
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 62
- From 26 Nov 2024 to the primary completion date, Apr 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- any malignancy
- chronic kidney disease
- 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
Lab values
- 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
Other
- mean ethanol consumption \>10 g/day
- liver cirrhosis
- uncontrolled hypothyroidism or hyperthyroidism
- use of any GnRH agonist or antagonist within a 12-month period before baseline
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 424 General Military Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| 1st Department of Obstetrics and Gynecology, School of Medicine, Aristotle University of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.