Actively Recruiting
Estrogen Administration for the Treatment of NASH in Postmenopausal Women
Led by Massachusetts General Hospital · Updated on 2025-08-03
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Non-alcoholic steatohepatitis (NASH), a progressive form of non-alcoholic fatty liver disease (NAFLD), is a growing concern especially among post-menopausal women who have a higher risk due to estrogen deficiency. Researchers are evaluating the effects of estradiol, a form of estrogen, on liver fat and fibrosis in post-menopausal women with NASH. This Phase 3 trial aims to understand how estradiol impacts disease progression in this population. Participants are randomly assigned to one of two groups: one group receives a daily transdermal estradiol patch delivering 100 mcg of estradiol, and women with an intact uterus also receive a daily vaginal progesterone tablet for endometrial protection. The other group receives placebo patches and vaginal placebo capsules. This study uses a quadruple-blind design to compare estradiol treatment with placebo over a 12-month period. During the trial, participants will undergo assessments to measure liver fat at 12 months. Eligibility includes postmenopausal women aged 45 to 70 years with confirmed NASH or NAFLD. Participants will be monitored for safety and adherence, and various health tests, including mammograms and liver biopsies or imaging, will be used to evaluate the effects of treatment. The total duration of participation is at least one year, with regular follow-ups for monitoring liver condition and overall health.
CONDITIONS
Brief Title
Estrogen Administration for the Treatment of NASH in Postmenopausal Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women aged 45 to 70 years
- Diagnosis of NASH by biopsy or NAFLD by imaging within 6 months before screening
- Negative hepatitis C antibody and hepatitis B surface antigen tests
- Negative mammogram within 1 year before enrollment
You will not qualify if you...
- Heavy alcohol use
- Use of NASH drugs within 12 months before study entry
- Known cirrhosis or stage 4 fibrosis or clinical signs of cirrhosis or portal hypertension
- Participation in another NASH clinical trial within 6 months before study entry
- Chronic use of corticosteroids, methotrexate, amiodarone, or tamoxifen within 6 months before entry
- Known chronic liver disease other than NAFLD
- Contraindications to liver biopsy such as high INR, low platelets, ascites, chronic anticoagulation, biliary obstruction, peritonitis, or inability to lie flat for 30 minutes
- Hemoglobin less than 10.0 g/dL or kidney filtration rate below 60 mL/min
- Contraindications to estrogen therapy
- Any vaginal bleeding or spotting within the last year
- Active cancer
- Severe chronic illness
- Use of estrogen or progesterone within 1 year before baseline
- Routine MRI exclusions like pacemaker or cerebral aneurysm clip presence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive either an estradiol patch or a placebo patch daily. Women with an intact uterus also receive progesterone or placebo vaginal tablets for endometrial protection.
Monthly visits for up to 12 months
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
C
Caitlin Dobbie, NP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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