Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function

Not Applicable

Completed

• Conditions: Menopause; Estrogen Deficiency; Cognitive Impairment; Endothelial Dysfunction; Vascular Stiffness
• Interventions: Other: GnRHant + E2; Other: GnRHant + Placebo

• Registration Number: NCT03112226
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Study Start: 2018-02-07
• Primary Completion: 2020-06-06
• Study Completion: 2020-06-21
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRHant + E2	GnRHant + E2	Single dose of GnRH antagonist degarelix acetate for depot injection (80mg) Transdermal estradiol add-back; Climara patch, 0.075mg/day, weekly for 12 weeks
GnRHant + Placebo	GnRHant + Placebo	Single dose of GnRH antagonist degarelix acetate for depot injection (80mg) Transdermal placebo patch, weekly for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes in Prefrontal cortex brain activation	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

Secondary Outcome Measures

Name	Time	Method
Changes in Endothelial function	Baseline, 3 months	Endothelial function will be measured using brachial artery flow-mediated dilation at baseline and 3 months
Changes in Arterial stiffness	Baseline, 3 months	Carotid artery compliance will be measured using ultrasound at baseline and 3 months
Changes in Executive cognitive function	Baseline, 3 months	Changes in executive cognitive function on a battery of neuropsychological tests will be measured at baseline and 3 months

Trial Locations

Locations (2)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

University of Colorado Boulder Intermountain Neuroimaging Consortium; 🇺🇸 Boulder, Colorado, United States