RECRUITING

Estrogen Administration for the Treatment of NASH in Postmenopausal Women

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Estrogen Administration for the Treatment of NASH in Postmenopausal Women

Quick Facts

Study Start:2021-12-02
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04833140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 70 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Postmenopausal women 45-70 years old
  2. * NASH by biopsy or NAFLD by imaging within 6 months of screen
  3. * Hepatitis C antibody and hepatitis B surface antigen negative
  4. * Negative mammogram within 1 year
  1. * Heavy alcohol use
  2. * Use of NASH pharmacotherapies within 12 months of study entry
  3. * Known cirrhosis, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam
  4. * Participation in NASH clinical trial within 6 months of study entry
  5. * Chronic use of corticosteroids, methotrexate, amiodarone, or tamoxifen within 6 months of entry
  6. * Known diagnosis of chronic liver disease other than NAFLD or found on biopsy
  7. * 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
  8. * Hgb \< 10.0 g/dL or glomerular filtration rate \< 60 mL/min
  9. * Contraindications to estrogen therapy
  10. * Any vaginal bleeding, including spotting, within the last year
  11. * Active malignancy
  12. * Severe chronic illness
  13. * Use of estrogen or progesterone within a year of baseline visit
  14. * Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip

Contacts and Locations

Study Contact

Caitlin Dobbie, NP
CONTACT
617-643-8635
cdobbie@mgb.org

Principal Investigator

Karen K. Miller, MD
PRINCIPAL_INVESTIGATOR
Massachsuetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Karen K. Miller, MD, PRINCIPAL_INVESTIGATOR, Massachsuetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-02
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2021-12-02
Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • NASH - Nonalcoholic Steatohepatitis