Non-alcoholic fatty liver disease (NAFLD) is a growing epidemic in the United States. Despite this, the treatment options remain limited. Preclinical and preliminary clinical data suggest that estrogen deficiency plays an important role in the pathology of steatosis, inflammation and fibrosis in non-alcoholic steatohepatitis (NASH), the progressive form of NAFLD. Post-menopausal women are a growing population with particularly high risk of NASH due to their lack of estrogen. This study will examine the effect of estradiol on hepatic fibrosis and fat in post-menopausal women with NASH.
Postmenopausal women 45-70 years old
NASH by biopsy or NAFLD by imaging within 6 months of screen
Hepatitis C antibody and hepatitis B surface antigen negative
Negative mammogram within 1 year
Heavy alcohol use
Use of NASH pharmacotherapies within 12 months of study entry
Known cirrhosis, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam
Participation in NASH clinical trial within 6 months of study entry
Parallel
Estradiol patch
DrugThe patch will provide 100mcg of estradiol daily.
Placebo
DrugPlacebo patch will contain no estradiol.
Liver fat
Reduction in amount of fat in the liver
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