MHT and Liver Function in Postmenopausal Women

Ipek B. Ozcivit Erkan, MD

Status: Completed

Conditions: Non Alcholic Fatty Liver Disease; Menopause; Hepatic Steatosis

Treatments: Drug: Menopausal hormone therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07103603

Approval Number:814468

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Group 1: MHT Group

Active Comparator group

Description:

Postmenopausal women receiving menopausal hormone therapy (oral or transdermal estrogen). Evaluated at baseline and after 6 months for liver function, lipid profile, FIB-4 score, and attenuation imaging.

Treatment:

Drug: Menopausal hormone therapy

Group 2: Control Group

No Intervention group

Description:

Postmenopausal women not receiving MHT. Monitored without treatment and evaluated using the same laboratory and imaging parameters.