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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 a particularly high risk of NASH due to their lack of estrogen. This study will examine the effect of estradiol on hepatic fat and fibrosis in post-menopausal women with NASH.

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This study is active but is not currently recruiting participants.

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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

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. Hepatic fat

    Time frame: 12 months

    Change in percentage of hepatic fat

Secondary outcomes

  1. Hepatic fibrosis

    Time frame: 12 months

    Decrease in hepatic fibrosis by ≥1 stage

  2. Non-alcoholic fatty liver disease activity score

    Time frame: 12 months

    Change in non-alcoholic fatty liver disease activity score (minimum value: 0; maximum value: 8; lower scores indicate less disease activity) without progression of fibrosis stage

  3. Whole liver transcriptome profile

    Time frame: 12 months

    Change in whole liver transcriptome profile

  4. Intrahepatic immune cell profiles

    Time frame: 12 months

    Change in intrahepatic immune cell profile

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2021
Registry last updated
Aug 7, 2026

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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