MHT and Liver Function in Postmenopausal Women

NCT07103603 | Completed

• 1 other identifier: Approval Number:814468
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Menopause; Non Alcholic Fatty Liver Disease; Hepatic Steatosis

Keywords

Menopausal hormone therapy; Non-alcoholic fatty liver disease; Liver function; Attenuation imaging; Hepatic steatosis; Postmenopausal women

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline and 6 months

Secondary Outcomes (3)

• Change in FIB-4 Score from baseline to 6 months

  Baseline and 6 months

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

  Baseline and 6 months

• Change in Lipid Profile (LDL, Total Cholesterol)

  Baseline and 6 months

Study Arms (2)

Group 1: MHT Group

ACTIVE COMPARATOR

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.

Drug: Menopausal hormone therapy

Group 2: Control Group

NO INTERVENTION

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

Interventions

Menopausal hormone therapy DRUG

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

Group 1: MHT Group

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Postmenopausal women aged 40 years and older were eligible for inclusion. Only biologically female participants were considered, as the study focused on the effects of estrogen deficiency and menopausal hormone therapy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipek B. Ozcivit Erkan, MD: lead

Study Sites (1)

Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine

Istanbul, Beyoğlu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease

Interventions

Hormone Replacement Therapy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Obstetrician and Gynecologist

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: October 30, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 27, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)