Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2024-10-30
2025-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1: MHT Group
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.
Menopausal hormone therapy
Menopausal hormone therapy including oral or transdermal estrogen, with or without progestin, administered based on clinical indications.
Group 2: Control Group
Postmenopausal women not receiving MHT. Monitored without treatment and evaluated using the same laboratory and imaging parameters.
No interventions assigned to this group
Interventions
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Menopausal hormone therapy
Menopausal hormone therapy including oral or transdermal estrogen, with or without progestin, administered based on clinical indications.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
FEMALE
No
Sponsors
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Ipek B. Ozcivit Erkan, MD
OTHER
Responsible Party
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Ipek B. Ozcivit Erkan, MD
Obstetrician and Gynecologist
Locations
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Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, Beyoğlu, Turkey (Türkiye)
Countries
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Other Identifiers
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Approval Number:814468
Identifier Type: -
Identifier Source: org_study_id
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