Estradiol for Perimenopause
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used hormones like birth control or hormone replacement in the past 3 months.
Is estradiol generally safe for use in perimenopausal women?
How does the drug Estradiol differ from other treatments for perimenopause?
Estradiol is unique because it can be administered in various forms such as patches, gels, or tablets, allowing flexibility in treatment. It directly supplements estrogen levels, which can help alleviate menopausal symptoms like hot flashes and mood swings, and is often combined with progestogens to prevent endometrial issues. This versatility and direct hormone replacement make it a distinct option compared to other treatments.36789
What evidence supports the effectiveness of the drug Estradiol for perimenopause?
Research shows that hormone replacement therapy (HRT) with estradiol can improve menopausal symptoms like hot flashes and mood swings, and may also help with bone health and cholesterol levels. A study found that a low-dose estrogen contraceptive relieved symptoms in perimenopausal women, suggesting that estradiol could be effective for similar issues.3891011
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive transdermal estradiol or placebo for 7 days to assess changes in endothelial function
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Estradiol
Estradiol is already approved in European Union, United States, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Delaware
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator