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Effects of Menopausal Hormone Therapy on Liver Function and Non-Alcoholic Fatty Liver Disease: A Prospective Study
This prospective study aims to evaluate the effects of menopausal hormone therapy (MHT) on liver function, lipid profiles, and hepatic steatosis in postmenopausal women. A total of 44 participants will be divided into two groups: 22 received MHT and 22 were monitored without treatment. Biochemical parameters, FIB-4 scores, and attenuation imaging (ATI) measurements are assessed at baseline and after six months. The study investigates whether MHT is associated with favorable changes in liver enzymes, hepatic fat accumulation, and noninvasive fibrosis markers.
This prospective, controlled cohort study is designed to evaluate the effects of menopausal hormone therapy (MHT) on liver function and non-alcoholic fatty liver disease (NAFLD) in postmenopausal women. A total of 44 participants are included and divided into two groups: 22 women will receive MHT and 22 will be monitored without treatment due to the absence of menopausal symptoms. Biochemical parameters including liver enzymes and lipid profiles are measured at baseline and after six months. In addition, hepatic steatosis is quantitatively assessed using attenuation imaging (ATI), a novel ultrasound-based technique, and FIB-4 scores are calculated as noninvasive indicators of liver fibrosis. The MHT regimens included both oral and transdermal estrogen, selected based on clinical indications. ATI measurements are performed using standardized protocols by radiologists blinded to clinical data. The primary aim of the study is to investigate whether MHT is associated with favorable changes in hepatic steatosis and liver-related biomarkers.
Age
40 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, Beyoğlu, Turkey (Türkiye)
Start Date
October 30, 2024
Primary Completion Date
September 30, 2025
Completion Date
December 30, 2025
Last Updated
January 27, 2026
44
ACTUAL participants
Menopausal hormone therapy
DRUG
Lead Sponsor
Ipek B. Ozcivit Erkan, MD
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06691178