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NCT04833140 · ClinicalTrials.gov record · last posted 2026-08-07

Estrogen Administration for the Treatment of NASH in Postmenopausal Women

StatusActive, Not Recruiting
PhasePhase 3
Started2021-12-02
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 5 changes detected by DataLookout

2026-08-05
notable
Enrollment closed, study ongoing
2026-08-05
critical
Primary endpoint(s) modified
WasLiver fat
NowHepatic fat
2026-08-05
notable
Enrollment reduced: 60 → 50 participants
2026-08-05
notable
Primary completion pushed: 2027-05-31 → 2027-07-09
2026-08-05
minor
Completion pushed: 2027-05-31 → 2027-07-09
Trial Details
NCT Number NCT04833140
Lead Sponsor Massachusetts General Hospital
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions NASH - Nonalcoholic Steatohepatitis
Enrollment 50 participants
Start Date 2021-12-02
Primary Completion 2027-07-09 (estimated)
Study Completion 2027-07-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-07