Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function

Cognitive Impairment Clinical Trial

Official title:

Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112226
• Other study ID #: 17-0092
• Status: Completed
• Phase: N/A
• Start date: February 7, 2018
• Est. completion date: June 21, 2020

Study information

• Verified date: June 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 21, 2020
• Est. primary completion date: June 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Endothelial Dysfunction
• Estrogen Deficiency
• Menopause
• Vascular Stiffness

Intervention

Other:
• GnRHant + E2
GnRH antagonist with estradiol add-back
• GnRHant + Placebo
GnRH antagonist with placebo add-back

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	University of Colorado Boulder Intermountain Neuroimaging Consortium	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Mitochondrial dysfunction	Measures of mitochondrial function including dynamics (fusion, fission), antioxidant defense and biogenesis will be measured in mitochondria isolated from peripheral blood mononuclear cells at baseline and 3 months.	Baseline and 3 months
Primary	Changes in Prefrontal cortex brain activation	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	Baseline, 3 months
Secondary	Changes in Endothelial function	Endothelial function will be measured using brachial artery flow-mediated dilation at baseline and 3 months	Baseline, 3 months
Secondary	Changes in Arterial stiffness	Carotid artery compliance will be measured using ultrasound at baseline and 3 months	Baseline, 3 months
Secondary	Changes in Executive cognitive function	Changes in executive cognitive function on a battery of neuropsychological tests will be measured at baseline and 3 months	Baseline, 3 months