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New treatment option for Metabolic Dysfunction-Associated Steatotic Liver Disease
Official title Effect of a GnRH Analog on Hepatic Steatosis
ClinicalTrials.gov ID: NCT06523530
What this study is testing
What is Goserelin Acetate 3.6 mg inj, implant?
Goserelin Acetate 3.6 mg inj, implant is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for metabolic dysfunction-associated steatotic liver disease.
Also referred to as Zoladex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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...
- use of contraceptives, which is the first line treatment, is contraindicated or the patient does not consent to receive contraceptives, due to...
- written informed consent to participate to the study
You likely can't join if
- 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...
- liver cirrhosis
- any malignancy
- chronic kidney disease
- uncontrolled hypothyroidism or hyperthyroidism
See the full eligibility 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...
- 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
- 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...
- 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...
- 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...
- use of any GnRH agonist or antagonist within a 12-month period before baseline
The study team makes the final eligibility decision.
Where it's taking place
- Thessaloniki, Greece
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thessaloniki, Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.