Estrogen Administration for the Treatment of NASH in Postmenopausal Women
Recruiting
Phase 3
Interventional Study
NASH - Nonalcoholic Steatohepatitis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 45 – 70
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Massachusetts General Hospital · Other
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About This Trial
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 growin…
Trial Locations
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Eligibility Criteria
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 with…
Contacts