Status:
RECRUITING
Estrogen Administration for the Treatment of NASH in Postmenopausal Women
Lead Sponsor:
Massachusetts General Hospital
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
FEMALE
45-70 years
Phase:
PHASE3
Brief Summary
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 estroge...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
- Chronic use of corticosteroids, methotrexate, amiodarone, or tamoxifen within 6 months of entry
- Known diagnosis of chronic liver disease other than NAFLD or found on biopsy
- Contraindication to liver biopsy including INR \> 1.5, platelets \< 50,000/mL, ascites, chronic anticoagulation (other than aspirin), biliary obstruction, peritonitis, inability to lie supine for 30 minutes
- Hgb \< 10.0 g/dL or glomerular filtration rate \< 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 a year of baseline visit
- Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip
Exclusion
Key Trial Info
Start Date :
December 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04833140
Start Date
December 2 2021
End Date
May 31 2027
Last Update
August 3 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114