Review article: the epidemiologic burden of non-alcoholic fatty liver disease across the world.
Linda Henry, James Paik, Zobair M Younossi
https://pubmed.ncbi.nlm.nih.gov/35880713Actively Recruiting
Phase 4
Age: 18Years - 45Years
FEMALE
ID06523530
Effect of the Pharmacological Cessation of Menstruation With a GnRH Analog on Hepatic Steatosis in Women With Endometriosis
Led by Aristotle University Of Thessaloniki · Updated on 2026-02-03
62
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
A
Aristotle University Of Thessaloniki
Lead Sponsor
4
424 General Military Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate how goserelin acetate, a gonadotropin-releasing hormone (GnRH) analog causing temporary menopause, affects liver fat buildup and fibrosis in women with endometriosis. Menopause is linked to increased risk of metabolic dysfunction-associated steatotic liver disease (MASLD) due to estrogen loss. Since GnRH treatment induces a reversible menopause state, it serves as a model to study menopause's impact on liver health in this prospective interventional study. Women with histologically confirmed endometriosis will be divided into two groups: 31 will receive monthly injections of goserelin acetate (3.6 mg subcutaneously) for six months, and 31 will not receive pharmacological treatment after surgery. The study will observe the effects of this pharmaceutical menopause on hepatic steatosis and fibrosis compared to no treatment. Participants will undergo assessments at baseline and after six months, including liver fat and fibrosis measurements, liver function tests, insulin resistance evaluation, lipid profiling, and various non-invasive indices related to liver health. Hormone levels and inflammatory markers will also be monitored. This study will last six months per participant, assessing changes due to the intervention and monitoring safety and liver status.
CONDITIONS
Brief Title
Effect of a GnRH Analog on Hepatic Steatosis
Who Can Participate
Age: 18Years - 45Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Women of reproductive age
- Diagnosis of endometriosis confirmed by surgery and biopsy
- Use of contraceptives is contraindicated or not consented due to personal preferences
- Written informed consent to participate in the study
You will not qualify if you...
- Mean ethanol consumption greater than 10 g/day
- History of other chronic liver diseases such as viral hepatitis, autoimmune hepatitis, or cirrhosis
- Any malignancy
- Chronic kidney disease
- Uncontrolled hypothyroidism or hyperthyroidism
- Severe sexual hormone disorders including congenital adrenal hyperplasia, Down syndrome, Turner syndrome
- Use of medications within 12 months before baseline that may cause liver injury or improve hepatic steatosis
- Use of any GnRH agonist or antagonist within 12 months before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 6 months
Participants receive monthly subcutaneous injections of goserelin acetate for 6 months to induce pharmaceutical menopause and assess its effect on hepatic steatosis.
6 monthly injections (in-person)
Trial Site Locations
Total: 2 locations
1
1st Department of Obstetrics and Gynecology, School of Medicine, Aristotle University of Thessaloniki
Thessaloniki, Greece, 56403
Actively Recruiting
2
424 General Military Hospital
Thessaloniki, Greece, 56429
Actively Recruiting
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Research Team
S
Stergios A Polyzos, MD, PhD
D
Dimitrios A Anastasilakis, MD, PhDc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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