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Hormone Therapy

Estrogen Therapy for NASH in Postmenopausal Women

Phase 3

Recruiting

Led By Karen K. Miller, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postmenopausal women 45-70 years old

Be older than 18 years old

Must not have

Chronic use of corticosteroids, methotrexate, amiodarone, or tamoxifen within 6 months of entry

Contraindications to estrogen therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Pivotal Trial

Summary

This trial will study the effect of the hormone estradiol on non-alcoholic steatohepatitis (NASH) in post-menopausal women. NASH is a growing epidemic in the United States with limited treatment options.

Who is the study for?

This trial is for postmenopausal women aged 45-70 with NASH or NAFLD, who haven't used estrogen or progesterone in the past year. They must have a negative hepatitis test and mammogram. Women with severe chronic illness, known cirrhosis, active cancer, certain blood conditions, or heavy alcohol use are excluded.

What is being tested?

The study tests if an estradiol patch can help reduce liver fibrosis and fat in postmenopausal women with NASH. Participants will either receive the estradiol patch or a placebo to compare effects.

What are the potential side effects?

Potential side effects of the estradiol patch may include skin irritation at the application site, headaches, breast tenderness, nausea, menstrual-like bleeding or spotting (even though participants are postmenopausal), and increased risk of blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 45-70 and have gone through menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken corticosteroids, methotrexate, amiodarone, or tamoxifen in the last 6 months.

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I cannot take estrogen therapy due to health risks.

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I have a chronic liver disease that is not NAFLD.

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My hemoglobin is below 10.0 g/dL or my kidney function is reduced.

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I have experienced vaginal bleeding or spotting in the last year.

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I have advanced liver disease, confirmed by tests or symptoms.

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I currently have cancer.

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I have a severe long-term health condition.

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I cannot have a liver biopsy due to certain health conditions or medications.

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I haven't used NASH medications in the last 12 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Liver fat

Liver fibrosis

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: EstradiolActive Control1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

Placebo patch (containing no estradiol) Women with an intact uterus will also receive vaginal placebo capsules (containing no progesterone)

0 / 11Eligibility criteria met