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Completed

NCT Number: NCT03112226

Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function

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.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Endothelial Dysfunction Estrogen Deficiency Menopause Mental Disorders Neurocognitive Disorders Vascular Stiffness

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GnRHant + E2

Other

GnRH antagonist with estradiol add-back

Other names: Degarelix acetate, Firmagon + Estradiol, Climara transdermal system

GnRHant + Placebo

Other

GnRH antagonist with placebo add-back

Other names: Degarelix acetate, Firmagon

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes in Endothelial function

    Time frame: Baseline, 3 months

    Endothelial function will be measured using brachial artery flow-mediated dilation at baseline and 3 months

  2. Changes in Arterial stiffness

    Time frame: Baseline, 3 months

    Carotid artery compliance will be measured using ultrasound at baseline and 3 months

  3. Changes in Executive cognitive function

    Time frame: Baseline, 3 months

    Changes in executive cognitive function on a battery of neuropsychological tests will be measured at baseline and 3 months

Other outcomes

  1. Changes in Mitochondrial dysfunction

    Time frame: Baseline and 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2017
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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