Clinical trial NCT03112226: Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function
Official title: Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Estrogen Deficiency
Menopause
Endothelial Dysfunction
Vascular Stiffness
Keywords: cognitive impairment
menopause
estrogen
functional MRI
executive function
endothelial function
arterial stiffness
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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
* Depression (Center for Epidemiological Studies - Depression (CESD) score \>16)
* Significant cognitive impairment (Mini Mental State Examination (MMSE) score \<27)
* Severe osteopenia or osteoporosis (proximal femur or lumbar spine T-score \< -2.0)
* Body Mass Index (BMI) \>40kg/m2

Primary outcomes:
measure: Changes in Prefrontal cortex brain activation
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Changes in Endothelial function
timeFrame: Baseline, 3 months
measure: Changes in Arterial stiffness
timeFrame: Baseline, 3 months
measure: Changes in Executive cognitive function
timeFrame: Baseline, 3 months
Other outcomes:
measure: Changes in Mitochondrial dysfunction
timeFrame: Baseline and 3 months
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Boulder
country: United States
facility: University of Colorado Boulder Intermountain Neuroimaging Consortium
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Kerry L Hildreth, MD
role: PRINCIPAL_INVESTIGATOR
References: