Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT07103603
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2025-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MHT and Liver Function in Postmenopausal Women
Sponsor:
Ipek B. Ozcivit Erkan, MD
Organization:
Study Overview
Official Title:
Effects of Menopausal Hormone Therapy on Liver Function and Non-Alcoholic Fatty Liver Disease: A Prospective Study
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: