Active — Not RecruitingPhase 3

Estrogen Administration for the Treatment of NASH in Postmenopausal Women

United States50 participantsStarted 2021-12-02

Plain-language summary

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.

Who can participate

Age range

45 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hepatic fat

Timeframe: 12 months

Trial details

NCT IDNCT04833140

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-09

View on ClinicalTrials.gov More NASH - Nonalcoholic Steatohepatitis trials