Estrogen Administration for the Treatment of NASH in Postmenopausal Women

Launched by MASSACHUSETTS GENERAL HOSPITAL · Apr 3, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of estrogen, specifically a hormone called estradiol, on women who have a liver condition known as Nonalcoholic Steatohepatitis (NASH). NASH is a more serious form of Nonalcoholic Fatty Liver Disease (NAFLD), which is becoming increasingly common, especially among postmenopausal women who have lower levels of estrogen. The researchers are looking to see if giving estradiol can help reduce liver fat and improve liver health in these women.

To participate in this study, women must be between 45 and 70 years old, postmenopausal, and have been diagnosed with NASH through a liver biopsy or imaging. They should not have any other serious liver diseases or certain health conditions that could interfere with the study. Participants will receive the treatment and be monitored over time to see how their liver condition changes. This trial is currently recruiting, and it’s a chance for eligible women to contribute to important research on a growing health issue.

Gender

FEMALE

Eligibility criteria

• 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