NCT04833140Active, not recruitingPhase 3
Estrogen Administration for the Treatment of NASH in Postmenopausal Women
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 3 Apr 2021
- Start date
- 2 Dec 2021
- Primary completion date
- 9 Jul 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04833140
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 50
- From 2 Dec 2021 to the primary completion date, 9 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic use of corticosteroids, methotrexate, amiodarone, or tamoxifen within 6 months of entry
- Contraindications to estrogen therapy
Other illness
- Known cirrhosis, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam
- Known diagnosis of chronic liver disease other than NAFLD or found on biopsy
- Any vaginal bleeding, including spotting, within the last year
- Active malignancy
- Severe chronic illness
Lab values
- 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
Other
- Heavy alcohol use
- Use of NASH pharmacotherapies within 12 months of study entry
- Participation in NASH clinical trial within 6 months of study entry
- 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
Who the study is looking for
- 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
Age in the registry: 45 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.