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Could estrogen patch reverse liver damage in postmenopausal women?

NCT ID NCT04833140

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This trial tests whether an estradiol patch can reduce liver fat and scarring in postmenopausal women with NASH, a progressive form of fatty liver disease. The study enrolls women aged 45-70 with NASH or fatty liver, giving them either a daily estradiol patch or a placebo for a period. Researchers will measure changes in liver fat, fibrosis, and related markers to see if replacing estrogen helps combat the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
estradiol patch
What this could lead to
If effective, estrogen replacement could become a treatment to slow or reverse liver damage in postmenopausal women with NASH.
What could go wrong
The trial is small (50 participants) and early-stage, so results may not apply broadly. Estrogen therapy carries risks like blood clots and breast cancer, which must be weighed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

50 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NASH - nonalcoholic steatohepatitis

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.