Using estrogen to treat NASH in postmenopausal women
Estrogen Administration for the Treatment of NASH in Postmenopausal Women
This study tests if an estrogen patch can help postmenopausal women with nonalcoholic steatohepatitis (NASH) improve their liver health.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | Female |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04833140 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of estradiol on hepatic fibrosis and fat in postmenopausal women diagnosed with nonalcoholic steatohepatitis (NASH). Given the increasing prevalence of NASH and the limited treatment options available, the study aims to address the role of estrogen deficiency in the disease's pathology. Participants will receive either an estradiol patch or a placebo, and their liver health will be monitored through biopsies and imaging. The trial focuses on a specific demographic that is particularly vulnerable to NASH due to hormonal changes after menopause.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 45-70 with a confirmed diagnosis of NASH or NAFLD.
Not a fit: Patients with known cirrhosis or other chronic liver diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for postmenopausal women suffering from NASH.
How similar studies have performed: While there is emerging evidence regarding estrogen's role in liver health, this specific approach in treating NASH is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 within 12 months of study entry * Known cirrhosis, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam * Participation in NASH clinical trial within 6 months of study entry * Chronic use of corticosteroids, methotrexate, amiodarone, or tamoxifen within 6 months of entry * Known diagnosis of chronic liver disease other than NAFLD or found on biopsy * Contraindication to liver biopsy including INR \> 1.5, platelets \< 50,000/mL, ascites, chronic anticoagulation (other than aspirin), biliary obstruction, peritonitis, inability to lie supine for 30 minutes * Hgb \< 10.0 g/dL or glomerular filtration rate \< 60 mL/min * Contraindications to estrogen therapy * Any vaginal bleeding, including spotting, within the last year * Active malignancy * Severe chronic illness * Use of estrogen or progesterone within a year of baseline visit * Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Karen K. Miller, MD — Massachsuetts General Hospital
- Study coordinator: Caitlin Dobbie, NP
- Email: cdobbie@mgb.org
- Phone: 617-643-8635
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.