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Estrogen Administration for NASH in Postmenopausal Women

This study is looking at how estradiol, delivered through a skin patch, might help treat Nonalcoholic Steatohepatitis (NASH) in postmenopausal women. NASH is a serious liver condition where fat builds up, causing inflammation and damage. Researchers believe that a lack of estrogen after menopause might contribute to NASH. This study will compare the estradiol patch (100mcg daily) to a placebo patch (no medicine) over 12 months. They want to see if estradiol can reduce liver fat. You might be able to join if you are a postmenopausal woman between 45 and 70 years old with NASH, and meet other health criteria. The study aims to enroll 60 participants.

Study design
This interventional study will enroll 60 postmenopausal women, comparing an estradiol patch to a placebo patch. The study's phase is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Liver fat will be measured at 12 months, indicating the study's duration for this primary outcome.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04833140

Estrogen Administration for the Treatment of NASH in Postmenopausal Women

Active, Not Recruiting
PHASE3Ages 45–70InterventionalTreatment
Massachusetts General Hospital
~50 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:Estradiol patchPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hepatic fat
Measured over 12 months

Conditions

NASH - Nonalcoholic Steatohepatitis

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Nonalcoholic Steatohepatitis

NCT04833140

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital

    Boston, Massachusettsno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Karen K. Miller, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Hepatic fat12 months

    Change in percentage of hepatic fat