Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function

University of Colorado, Denver2 sites in 1 country19 target enrollmentFebruary 7, 2018

ConditionsCognitive Impairment Estrogen Deficiency Menopause Endothelial Dysfunction Vascular Stiffness

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cognitive Impairment
Sponsor: University of Colorado, Denver
Enrollment: 19
Locations: 2
Primary Endpoint: Changes in Prefrontal cortex brain activation
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Complaints about memory and thinking are common in women as they go through menopause. The female hormone estrogen is important for both the health of both the brain and the blood vessels. In Alzheimer's disease there is damage to the blood vessels in the brain. This study will look at how the loss of the female hormone estrogen affects brain function and the health of blood vessels.

Registry

clinicaltrials.gov

Start Date

February 7, 2018

End Date

June 21, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Colorado, Denver

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Stages of Reproductive Aging Workshop (STRAW+10) peak or late reproductive stage (-4, -3b or -3a)
•Healthy based on medical history, physical examination and standard blood chemistries
•Normotensive (resting blood pressure \<140/90 mmHg)
•Normoglycemia (fasting glucose \<110mg/dl and hemoglobin A1c\<6.5%)
•Non-smoker (for at least 12 months)

Exclusion Criteria

•Serum Follical Stimulating Hormone (FSH) \>25mIU/mL measured during the first 5 days of the menstrual cycle
•Use of hormonal therapy within the past 3 months
•Use of antihypertensive or lipid-lowering medications
•Pregnant or lactating, or planning to become pregnant during the study period
•Known hypersensitivity to any of the study medications
•Abnormal vaginal bleeding
•History of venous thromboembolism or hormone-sensitive cancer
•History of neurologic disease or major psychiatric illness
•History of diagnosed learning disability or less than high-school education
•Contraindication to Magnetic Resonance Imaging (MRI) scanning

Outcomes

Primary Outcomes

Changes in Prefrontal cortex brain activation

Time Frame: Baseline, 3 months

Changes in patterns of brain activation in the prefrontal cortex using functional magnetic resonance imaging (fMRI) during a task of working memory will be measured at baseline and 3 months