MenopauseNCT07103603
MHT and Liver Function in Postmenopausal Women
A study testing Menopausal hormone therapy in people with Menopause and Non Alcholic Fatty Liver Disease, run by Ipek B. Ozcivit Erkan, MD at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Menopause, Non Alcholic Fatty Liver Disease, Hepatic Steatosis
- What is being tested?
- Menopausal hormone therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, Beyoğlu
About this study
Official title: 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.
Read the detailed 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.
- Being tested
- Menopausal hormone therapy
- Keywords
- Menopausal hormone therapy, Non-alcoholic fatty liver disease, Liver function, Attenuation imaging, Hepatic steatosis, Postmenopausal women
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menopausal hormone therapyDrug
Menopausal hormone therapy including oral or transdermal estrogen, with or without progestin, administered based on clinical indications.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (3)
Change in FIB-4 Score from baseline to 6 months
Assessment of liver fibrosis using FIB-4 score formula: [Age × AST] / [Platelet × √ALT]. Lower scores indicate less fibrosis.
Measured: Baseline and 6 months
Change in Liver Enzyme Levels (AST, ALT, GGT, LDH)
Serum levels of AST, ALT, GGT, and LDH measured through standard laboratory assays to evaluate liver function.
Measured: Baseline and 6 months
Change in Lipid Profile (LDL, Total Cholesterol)
Evaluation of lipid metabolism via total cholesterol and LDL levels to assess metabolic effects of MHT.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start30 Oct 2024
- Primary completion30 Sep 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipek B. Ozcivit Erkan, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ipek B. Ozcivit Erkan, MD, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103603
- Sponsor's protocol ID
- Approval Number:814468
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual data will be made available upon reasonable request from the corresponding author for academic and non-commercial use.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Menopausal Hormone Therapy on Liver Function and Non-Alcoholic Fatty Liver Disease: A Prospective Study
- ClinicalTrials.gov ID
- NCT07103603
- Acronym / sponsor ID
- Approval Number:814468
- Keywords
- Menopausal hormone therapy, Non-alcoholic fatty liver disease, Liver function, Attenuation imaging, Hepatic steatosis, Postmenopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ipek B. Ozcivit Erkan, MDUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: MHT Group | Active comparator | Drug: Menopausal hormone therapyPostmenopausal 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. |
| Group 2: Control Group | No intervention | –Postmenopausal women not receiving MHT. Monitored without treatment and evaluated using the same laboratory and imaging parameters. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menopausal hormone therapyMenopausal hormone therapy including oral or transdermal estrogen, with or without progestin, administered based on clinical indications. | Drug | Group 1: MHT Group |
Primary outcome
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.
3 secondary outcomes
Change in FIB-4 Score from baseline to 6 months
Time frame: Baseline and 6 months
Change in Liver Enzyme Levels (AST, ALT, GGT, LDH)
Time frame: Baseline and 6 months
Change in Lipid Profile (LDL, Total Cholesterol)
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. De-identified individual data will be made available upon reasonable request from the corresponding author for academic and non-commercial use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menopausal hormone therapy in people with Menopause and Non Alcholic Fatty Liver Disease, run by Ipek B. Ozcivit Erkan, MD at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ATI (Attenuation Imaging) value from baseline to 6 months (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.