drugset / Trial / NCT04833140

Estrogen Administration for the Treatment of NASH in Postmenopausal Women

NCT04833140

Phase 3 Recruiting 60 enrolled Massachusetts General Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-12-02
Primary completion
2027-05-31
Completion
2027-05-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Estradiol Other / unclassified 100 ug Other