Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function
Completed · Not applicable · Has a placebo group
Conditions studied: Cognitive Impairment, Estrogen Deficiency, Menopause, Endothelial Dysfunction, Vascular Stiffness
In brief
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.
Key facts
- Study ID
- NCT03112226
- Run by
- University of Colorado, Denver
- People needed
- 19
- Starts
- 2018-02-07
- Expected to finish
- 2020-06-21
- Last updated by the study team
- 2021-06-07
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- University of Colorado Boulder Intermountain Neuroimaging Consortium — Boulder, Colorado, United States
Full record on ClinicalTrials.gov
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