Learning How Estradiol Patches Affect Health and Well-Being After Menopause

This research study wants to learn more about how estradiol patch treatment affects brain function, health and wellbeing in healthy women who have experienced menopause.


Why this Research Matters

Estradiol is a hormone that helps regulate the menstrual cycle. Estradiol patches are commonly used to help manage menopause symptoms in older women. However, we do not understand how different estradiol patch schedules may affect the overall health in women who have experienced menopause. This study can help researchers learn more about how hormone therapy may affect women after menopause. If you want to be in the study, you will first have to attend a virtual visit where we will ask you questions about your health. If you are eligible, you will then have an in-person visit at the University of Colorado Anschutz. You will need to fast before this visit. We will also ask you to complete two brain imaging scans (an MRI and an EEG) and different thinking tests. We will also collect blood, saliva, and hair samples. If you decide to join the study, you will be assigned to one of two groups. One group will wear estradiol patches for up to 86 days. The other group will wear estradiol patches for four days in a row every 21 days for 12 weeks. While taking study treatment, you will complete symptom diaries at home and provide urine samples using a home urine hormone monitoring device at certain timepoints. You will also attend 8 mobile lab visits where blood samples will be collected. After the treatment ends, you will take progesterone pills for 14 days. You will then complete one final in-person visit and a virtual visit. There is no cost to participate in the study. You may earn up to $695 if you are assigned to group one or up to $794 if you are assigned to group two. Participation lasts about four months and includes up to 12 study visits.


Who can Participate

Adult

You may be able to join this study if you are between 38 and 60 years old, your final menstrual period was 12 to 48 months ago, and you have not used estradiol in the past year. You may not be eligible to participate if you have a mental health condition, a history of substance use disorder, or a recent history of suicidal behavior. You also may not be eligible if you currently have or have had a history of breast cancer, blood clots, liver disease, or heart disease.


Study ID

Protocol Number: 25-2688


Compensation Information

Compensation
Study Payment: Compensation provided.

Meet the Team

Image of Principal Investigator

Cynthia Epperson, MD

Principal Investigator