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Completed

NCT Number: NCT07103603

MHT and Liver Function in Postmenopausal Women

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.

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Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine

Istanbul, Beyoğlu, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female participants aged 40 years or older
  • Postmenopausal status (defined as ≥12 months of amenorrhea)
  • No prior use of menopausal hormone therapy in the last 6 months
  • Willingness to participate and provide informed consent

Exclusion criteria

  • History of liver disease, liver malignancy, or liver transplantation
  • Current or past alcohol consumption exceeding 20g/day
  • Premature ovarian failure
  • History of any active malignancy
  • Use of medications known to affect liver enzymes or fat metabolism
  • Current participation in another clinical trial

Treatment and study plan

Menopausal hormone therapy

Drug

Menopausal hormone therapy including oral or transdermal estrogen, with or without progestin, administered based on clinical indications.

Primary outcomes

  1. Change in ATI (Attenuation Imaging) value from baseline to 6 months

    Time frame: Baseline and 6 months

    Quantitative measurement of hepatic steatosis using ultrasound-based attenuation imaging (ATI). A decrease in ATI indicates improvement in hepatic fat content.

Secondary outcomes

  1. Change in FIB-4 Score from baseline to 6 months

    Time frame: Baseline and 6 months

    Assessment of liver fibrosis using FIB-4 score formula: [Age × AST] / [Platelet × √ALT]. Lower scores indicate less fibrosis.

  2. Change in Liver Enzyme Levels (AST, ALT, GGT, LDH)

    Time frame: Baseline and 6 months

    Serum levels of AST, ALT, GGT, and LDH measured through standard laboratory assays to evaluate liver function.

  3. Change in Lipid Profile (LDL, Total Cholesterol)

    Time frame: Baseline and 6 months

    Evaluation of lipid metabolism via total cholesterol and LDL levels to assess metabolic effects of MHT.

Sponsors and collaborators

Lead sponsor

Ipek B. Ozcivit Erkan, MD

Other

Registry information

Official study title

Effects of Menopausal Hormone Therapy on Liver Function and Non-Alcoholic Fatty Liver Disease: A Prospective Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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