CEREBRA Study
This project will test whether cyclic versus continuous estradiol administration differentially influences brain, metabolic, immune, and stress systems, as well as behavioral (mood, sleep, activity, perceived stress) and cognitive (memory, attention, decision-making, processing speed) outcomes in healthy early postmenopausal women.
Why this Research Matters
This study is designed to evaluate how different estradiol patch dosing regimens affect brain function, cognition, stress biology, and overall health in early postmenopausal women. Participants will be randomized to receive either continuous estradiol patch treatment or a cyclic estradiol dosing regimen over approximately 12-13 weeks. While estradiol is an FDA approved therapy for menopausal symptoms, the cyclic dosing schedule used in this study is investigational and intended to better understand differences in hormone exposure patterns. Participants will complete a combination of virtual, in-person, and at home study procedures across approximately 4 months. Two in-person visits at the University of Colorado Anschutz Medical Campus will include neuroimaging (MRI), electroencephalography (EEG), cognitive and behavioral assessments, and collection of biological samples including blood, saliva, and a hair sample to measure cortisol levels. During the treatment phase, participants will complete at-home symptom diaries, provide urine samples at specified timepoints, and participate in multiple mobile lab visits for blood collection. Participants will begin estradiol treatment following the baseline visit, with the first patch applied during a Day 1 mobile lab visit after initial blood sampling. Hormone levels will be monitored throughout the study, including use of a home urine hormone monitoring device to measure estradiol levels at select timepoints. At the conclusion of the estradiol treatment period, participants with will take oral progesterone for 14 days. The primary goal of the study is to identify how different estradiol dosing patterns influence neural activity, executive function, motivation, and stress-related biological systems. Findings from this study may help inform more personalized approaches to menopausal hormone therapy and improve understanding of how hormone treatment impacts brain health and functioning in postmenopausal women.
Who can Participate
Ages 38 to 60 Between 12 months and 48 months since final menstrual period No estradiol use in past 12 months Right-handed
Study ID
Protocol Number: 25-2688
Meet the Team
Principal Investigator