Estrogen Administration for the Treatment of NASH in Postmenopausal Women

Who is this study for? Patients with Nonalcoholic Fatty Liver Disease
What treatments are being studied? Estradiol Patch
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 45
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Caitlin Dobbie, NP
cdobbie@mgb.org
617-643-8635
Time Frame
Start Date: 2021-12-02
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 60
Treatments
Active_comparator: Estradiol
Estradiol in the form of a transdermal patch 100 mcg daily (Vivelle-Dot generic).~Women with an intact uterus will also receive progesterone (100 mg) in the form of a vaginal tablet (Endometrin, Ferring Pharmaceuticals, Inc.) inserted daily for endometrial protection
Placebo_comparator: Placebo
Placebo patch (containing no estradiol) Women with an intact uterus will also receive vaginal placebo capsules (containing no progesterone)
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov