| Registry | NCT04833140 |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 50 (Actual) |
| Sponsor | Massachusetts General Hospital (Other); collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Conditions | NASH - Nonalcoholic Steatohepatitis |
| Interventions | Estradiol patch, Placebo (Drug) |
| Dates | start 2021-12-02, primary completion 2027-07-09 (estimated), completion 2027-07-09 (estimated), first posted 2021-04-06, last updated 2026-08-07 |
| Locations | 1 site in United States |
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All trials for NASH - Nonalcoholic Steatohepatitis All trials of Estradiol patch All trials of Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Estradiol | Active comparator | Drug: Estradiol patch | Estradiol in the form of a transdermal patch 100 mcg daily (Vivelle-Dot generic). Women with an intact uterus will also receive progesterone (100 mg) in the form of a vaginal tablet (Endometrin, Ferring Pharmaceuticals, Inc.) inserted daily for endometrial protection |
| Placebo | Placebo comparator | Drug: Placebo | Placebo patch (containing no estradiol) Women with an intact uterus will also receive vaginal placebo capsules (containing no progesterone) |
Sex: Female, ages: 45 Years to 70 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Massachusetts General Hospital | Boston, Massachusetts | United States |
NIH grants: R01DK126955