Estrogen Administration for the Treatment of NASH in Postmenopausal Women

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04833140
Phase
PHASE3
Status
Recruiting
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Conditions

  • NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Estradiol patch — DRUG
    The patch will provide 100mcg of estradiol daily.
  • Placebo — DRUG
    Placebo patch will contain no estradiol.

Study Details

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.

Key Dates

Start date
Dec 2, 2021
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Liver fat [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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Massachusetts General Hospital· Boston, MA

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