60 Participants Needed

Estrogen Therapy for NASH in Postmenopausal Women

AG
CD
Overseen ByCaitlin Dobbie, NP
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you have not used certain medications like NASH treatments, corticosteroids, methotrexate, amiodarone, tamoxifen, estrogen, or progesterone within specific time frames before joining. If you are on these medications, you may need to stop them to participate.

Is estrogen therapy using transdermal patches safe for postmenopausal women?

Estrogen therapy using transdermal patches like Estraderm and Climara is generally safe for postmenopausal women, with the most common side effect being mild skin irritation at the patch site. Some studies suggest a potential increased risk of breast cancer with long-term use, so more research is needed. The patches do not adversely affect liver proteins or lipid levels, and they avoid some risks associated with oral estrogen therapy.12345

How is the Estradiol patch treatment for NASH in postmenopausal women different from other treatments?

The Estradiol patch is unique for NASH treatment as it involves hormone therapy using estrogen, which is not a standard approach for this condition. Unlike other treatments that target liver-specific pathways, this therapy may offer benefits related to hormone replacement, particularly in postmenopausal women.678910

What data supports the effectiveness of the drug Estradiol patch for treating NASH in postmenopausal women?

Research shows that transdermal estradiol patches, like Estraderm and Climara, are effective in reducing menopausal symptoms and may decrease the risk of osteoporosis. They also avoid some risks associated with oral estrogen, such as increased blood pressure, by bypassing the liver.1231112

Who Is on the Research Team?

KK

Karen K Miller, MD

Principal Investigator

Massachsuetts General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Hepatitis C antibody and hepatitis B surface antigen negative
Negative mammogram within 1 year
I am a woman aged 45-70 and have gone through menopause.
See 1 more

Exclusion Criteria

I have used estrogen or progesterone in the past year.
I haven't taken corticosteroids, methotrexate, amiodarone, or tamoxifen in the last 6 months.
I cannot take estrogen therapy due to health risks.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive estradiol or placebo via transdermal patch for 12 months

12 months
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Estradiol patch
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: EstradiolActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Estradiol patch is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Estraderm for:
🇪🇺
Approved in European Union as Vivelle for:
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Approved in Canada as Climara for:
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Approved in Japan as Estradiol Transdermal System for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Published Research Related to This Trial

Transdermal estrogen replacement therapy in 32 menopausal women who had undergone liver transplantation was found to be safe, as it did not impair liver function or cause thrombotic effects over a 6-month follow-up period.
The treatment effectively achieved desired hormonal effects, as confirmed by biochemical markers and transvaginal ultrasound, indicating that transdermal estrogen can be safely combined with immunosuppressive drugs post-transplant.
Safety and efficacy of transdermal estradiol replacement therapy in postmenopausal liver transplanted women. A preliminary report.Appelberg, J., Isoniemi, H., Nilsson, CG., et al.[2019]
The Estraderm Transdermal System, which delivers 17-beta estradiol, is an effective method for estrogen replacement therapy, providing relief from climacteric symptoms similar to oral estrogens, with localized skin irritation as the primary side effect in about 15% of users.
Transdermal estrogen therapy may have advantages over oral estrogen, such as bypassing the liver to reduce risks associated with blood pressure elevation, but there are concerns about an increased risk of breast cancer, highlighting the need for further long-term studies.
Estrogen replacement therapy and the estraderm transdermal system.Youngkin, EQ.[2013]
The 7-day estradiol transdermal patch (Climara) effectively reduces hot flushes in women, with a mean decline of 74.6% for the higher dose compared to 64.5% for the lower dose, showing comparable efficacy to traditional hormone therapies.
The Climara patch is well tolerated, with a low withdrawal rate due to adverse events (8.9%), primarily related to skin reactions, and it demonstrated better adhesion compared to other patches, making it a practical option for estrogen replacement therapy.
Clinical experience with a seven-day estradiol transdermal system for estrogen replacement therapy.Gordon, SF.[2019]

Citations

Safety and efficacy of transdermal estradiol replacement therapy in postmenopausal liver transplanted women. A preliminary report. [2019]
Estrogen replacement therapy and the estraderm transdermal system. [2013]
Clinical experience with a seven-day estradiol transdermal system for estrogen replacement therapy. [2019]
The effect of site of application on the transcutaneous absorption of 17-beta estradiol from a transdermal delivery system (Climara). [2019]
A comparative multicenter study of two transdermal estradiol replacement therapies in the treatment of postmenopausal symptoms. [2013]
Clinical experience with a 7-day estrogen patch: principles and practice. [2013]
Clinical experience with transdermal estradiol in the treatment of the climacteric. [2013]
Nonalcoholic Fatty Liver Disease: A Drug Revolution Is Coming. [2021]
Emerging drugs for non-alcoholic steatohepatitis. [2014]
Pharmacotherapy of nonalcoholic steatohepatitis: Reflections on the existing evidence. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
The therapeutic landscape of non-alcoholic steatohepatitis. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
New drugs for NASH. [2021]
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