Can a menopause-mimicking drug fight fatty liver in endometriosis patients?
NCT ID NCT06523530
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times
Summary
This study tests whether goserelin acetate, a drug that temporarily stops menstruation (like a short-term menopause), can reduce liver fat in women with endometriosis who also have fatty liver disease. Researchers will measure liver fat and stiffness using ultrasound in 62 women over 6 months. The goal is to see if this approach can improve liver health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Goserelin acetate (Zoladex), a drug that temporarily stops menstruation
- What this could lead to
- If it works, this could point toward a new way to treat fatty liver disease in women with endometriosis by using a temporary menopause-like state.
- What could go wrong
- This is a small, early-phase trial with only 62 participants. The drug causes temporary menopause, which may have side effects like hot flashes and bone thinning, and the liver benefit is not yet proven.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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1st Department of Obstetrics and Gynecology, School of Medicine, Aristotle University of Thessaloniki
Thessaloniki, 56403, Greece
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424 General Military Hospital
Thessaloniki, Thessaloniki, 56429, Greece
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can ultrasound and tissue clues reveal which endometriosis lesions carry cancer risk?
- Can exercise melt away liver fat?