Estrogen Administration for the Treatment of NASH in Postmenopausal Women

NASH - Nonalcoholic Steatohepatitis Clinical Trial

Official title:

Estrogen Administration for the Treatment of NASH in Postmenopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833140
• Other study ID #: 2021P001506
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2, 2021
• Est. completion date: May 31, 2027

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: Anu Gerweck, NP
• Phone: 617-724-1837
• Email: avgerweck[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• Estradiol patch
The patch will provide 100mcg of estradiol daily.
• Placebo
Placebo patch will contain no estradiol.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver fibrosis	Reduction in degree of liver fibrosis	12 months
Primary	Liver fat	Reduction in amount of fat in the liver	12 months