Actively Recruiting
Estrogen Administration for the Treatment of NASH in Postmenopausal Women
Led by Massachusetts General Hospital · Updated on 2025-08-03
60
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Estrogen Administration for the Treatment of NASH in Postmenopausal Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women 45-70 years old
- Diagnosis of NASH by biopsy or NAFLD by imaging within 6 months before screening
- Negative hepatitis C antibody and hepatitis B surface antigen tests
- Negative mammogram within 1 year prior to enrollment
You will not qualify if you...
- Heavy alcohol use
- Use of NASH pharmacotherapies within 12 months before study entry
- Known cirrhosis, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension
- Participation in another NASH clinical trial within 6 months before study entry
- Chronic use of corticosteroids, methotrexate, amiodarone, or tamoxifen within 6 months before study entry
- Known chronic liver disease other than NAFLD
- Contraindications to liver biopsy including INR > 1.5, platelets < 50,000/mL, ascites, chronic anticoagulation (except aspirin), biliary obstruction, peritonitis, or inability to lie supine for 30 minutes
- Hemoglobin less than 10.0 g/dL or glomerular filtration rate less than 60 mL/min
- Contraindications to estrogen therapy
- Any vaginal bleeding, including spotting, within the last year
- Active malignancy
- Severe chronic illness
- Use of estrogen or progesterone within 1 year prior to baseline visit
- Routine MRI exclusion criteria such as presence of a pacemaker or cerebral aneurysm clip
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
C
Caitlin Dobbie, NP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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