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NCT Number: NCT04833140

Estrogen Administration for the Treatment of NASH in Postmenopausal Women

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.

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Key information

Conditions

NASH - Nonalcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estradiol patch

Drug

The patch will provide 100mcg of estradiol daily.

Placebo

Drug

Placebo patch will contain no estradiol.

Primary outcomes

  1. Liver fat

    Time frame: 12 months

    Reduction in amount of fat in the liver

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin Dobbie, NP

CONTACT

[email protected]

617-643-8635

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2021
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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