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RECRUITING
NCT04833140
PHASE3

Estrogen Administration for the Treatment of NASH in Postmenopausal Women

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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 particularly high risk of NASH due to their lack of estrogen. This study will examine the effect of estradiol on hepatic fibrosis and fat in post-menopausal women with NASH.

Key Details

Gender

FEMALE

Age Range

45 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-12-02

Completion Date

2027-05-31

Last Updated

2025-08-03

Healthy Volunteers

No

Interventions

DRUG

Estradiol patch

The patch will provide 100mcg of estradiol daily.

DRUG

Placebo

Placebo patch will contain no estradiol.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States