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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am a woman aged 45-70 and have gone through menopause.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Liver fat
Liver fibrosis

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)

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,421 Total Patients Enrolled
14 Trials studying Non-alcoholic Fatty Liver Disease
787 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Karen K. Miller, MDPrincipal InvestigatorMassachsuetts General Hospital
1 Previous Clinical Trials
142 Total Patients Enrolled

Media Library

Estradiol patch (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04833140 — Phase 3
Non-alcoholic Fatty Liver Disease Research Study Groups: Estradiol, Placebo
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Estradiol patch Highlights & Side Effects. Trial Name: NCT04833140 — Phase 3
Estradiol patch (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04833140 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical purposes is Estradiol most often employed?

"Estradiol is commonly used to treat amenorrhea, or the absence of a menstrual period, but can also be given to patients experiencing other conditions such as hypoestrogenism and vasomotor menopausal symptoms."

Answered by AI

Are elderly patients allowed to participate in this clinical research?

"The study's 45 to 70-year-old age bracket is an inclusion criterion for this particular trial. There are 30 clinical trials that test on patients under the age of 18 and 218 for those 65 and older."

Answered by AI

Would I be able to qualify for participation in this research?

"Currently, this clinical trial is looking for 60 post-menopausal women aged 45 to 70 that have fatty liver."

Answered by AI

What is the governmental organization's stance on Estradiol?

"Estradiol, which is currently being trialed in Phase 3, has received a safety score of 3 from our team at Power. This is based on the efficacy data that exists as well as multiple rounds of supporting safety data."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Massachusetts General Hospital
Recent research and studies
clinicaltrials.govStudy
Estrogen Administration for the Treatment of NASH in Postmenopausal Women
Karen Klahr Miller, MD 2021. "Estrogen Administration for the Treatment of NASH in Postmenopausal Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04833140.
All > Fatty Liver Disease > Nash
~34 spots leftby May 2027
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