Effect of a GnRH Analog on Hepatic Steatosis

What Was Tested

The trial (phase 4) is built around Goserelin for endometriosis and fatty liver & elevated liver enzymes.

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.

It had two arms (groups): Goserelin (experimental) and Control (no intervention).

31 women with histologically confirmed endometriosis will receive goserelin acetate post-surgically.

The registry classes the interventions as drug.

More on the Plan

Owing to the epidemiologic and pathophysiologic association of MASLD with obesity, type 2 diabetes mellitus, dyslipidemia and arterial hypertension, the diagnostic criteria for MASLD are similar to those of the metabolic syndrome.

Regarding the effect of the lack of estrogen on the liver, most to date data are derived from experimental studies, largely showing a favoring effect on MASLD.

However, existing clinical studies are mostly observational, thereby not being able to show a causative association between menopause and MASLD.

Who Took Part

The registry lists 62 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women of reproductive age. 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.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: liver cirrhosis; any malignancy; chronic kidney disease.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The Goserelin group and the comparison group ran side by side rather than switching.

Everyone knew when Goserelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-11-26 with completion listed for 2027-04.

It ran at 2 sites in Greece (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Hepatic steatosis (time frame: 6 months). Hepatic fibrosis (time frame: 6 months).

It also tracked 22 secondary outcomes, for example Liver function tests I - ALT and AST, Liver function tests II - γGT, Insulin resistance, Lipid profile, Non-invasive hepatic steatosis index I - Fatty Liver Index (FLI) and Non-invasive hepatic steatosis index II - Hepatic Steatosis Index (HSI).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Goserelin in 62 people with endometriosis.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, Endometriosis research, Fatty liver & elevated liver enzymes research.