What is the mechanism of action of this treatment?

Hormonal treatments for perimenopause, such as estradiol (E2), work primarily by supplementing declining estrogen levels, which helps alleviate symptoms like hot flashes, mood swings, and vaginal dryness. Estradiol, a form of estrogen, can improve vascular endothelial function, which is crucial for cardiovascular health. This is particularly important for perimenopausal patients as they experience hormonal fluctuations that can lead to endothelial dysfunction, increasing the risk of cardiovascular diseases. By stabilizing estrogen levels, these treatments help maintain vascular health and overall well-being during the perimenopausal transition.

What side effects are associated with this type of intervention?

Common treatments for perimenopause, particularly those involving estradiol (E2) and other hormonal therapies, can have several side effects. For estrogen-alone therapy, potential side effects include an increased risk of pulmonary embolism and hip fractures, though it may reduce the risk of coronary heart disease and invasive breast cancer. Combined estrogen-progestin therapy can increase the risk of coronary heart disease, invasive breast cancer, stroke, and pulmonary embolism, but it may reduce the risk of colorectal cancer and hip fractures. Both therapies can also impact cognitive function and mood, with some evidence suggesting that they may not significantly improve cognitive performance and could potentially increase anxiety and depression.

What prior FDA approvals exist?

The FDA has approved several treatments for perimenopausal symptoms, particularly those involving hormonal regulation. Estradiol (E2), a form of estrogen, is commonly used in various formulations such as patches, gels, and pills to manage symptoms like hot flashes and vaginal dryness. Other FDA-approved hormone therapies include conjugated estrogens and medroxyprogesterone acetate, often used in combination to reduce the risk of endometrial cancer in women with an intact uterus. These treatments aim to alleviate vasomotor symptoms and improve overall quality of life during perimenopause.

What other types of research exist?

Promising alternatives to Estradiol (E2) for perimenopausal patients include SSRIs/SNRIs such as venlafaxine, desvenlafaxine, paroxetine, citalopram, and escitalopram for their rapid and effective management of menopausal symptoms. Additionally, micronized progesterone is a preferred progestin due to its effectiveness and safety profile.

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Hormone Therapy

Estradiol for Perimenopause

Phase 4

Recruiting

Research Sponsored by University of Delaware

Eligibility Criteria Checklist

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

Must have

Live in Delaware

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to day 7

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial studies how estradiol, a form of estrogen, affects blood vessel health in peri-menopausal women. The goal is to see if estradiol can improve the function of cells lining the blood vessels, potentially reducing the risk of cardiovascular disease. Estradiol has been shown to reduce cardiovascular disease by direct and indirect effects on the cardiovascular system, with recent evidence suggesting beneficial actions of its metabolites.

Who is the study for?

This trial is for peri-menopausal women aged 40-58 living in Delaware, experiencing changes in their menstrual cycles or short-term amenorrhea. It's not open to those with cardiovascular disease, blood clots, stroke, cancer, liver disease, extreme body weights (BMI <18 or >30), tobacco users, pregnant/breastfeeding women, high blood pressure patients not controlled without medication.

What is being tested?

The study tests the effects of Estradiol patches on vascular endothelial function in peri-menopausal women. Participants will either receive the Estradiol patch or a placebo to compare outcomes and understand how advancing reproductive age affects vascular health.

What are the potential side effects?

While specific side effects are not listed here, typical ones associated with hormone treatments like Estradiol may include skin irritation at the patch site, headaches, breast tenderness/pain and nausea.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to day 7 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Vascular Endothelial Function (Flow mediated dilation or FMD)

Secondary study objectives

Endothelial Cell Protein Expression

Endothelin Receptor Responses

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EstradiolExperimental Treatment1 Intervention

Transdermal estradiol (0.1mg/day patch)

Group II: PlaceboPlacebo Group1 Intervention

Placebo

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hormonal treatments for perimenopause, such as estradiol (E2), work primarily by supplementing declining estrogen levels, which helps alleviate symptoms like hot flashes, mood swings, and vaginal dryness. Estradiol, a form of estrogen, can improve vascular endothelial function, which is crucial for cardiovascular health. This is particularly important for perimenopausal patients as they experience hormonal fluctuations that can lead to endothelial dysfunction, increasing the risk of cardiovascular diseases. By stabilizing estrogen levels, these treatments help maintain vascular health and overall well-being during the perimenopausal transition.

MPA and postmenopausal coronary artery atherosclerosis revisited.