Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function
NCT ID: NCT03112226
Last Updated: 2021-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2018-02-07
2020-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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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 + E2
GnRH antagonist with estradiol add-back
GnRHant + Placebo
Single dose of GnRH antagonist degarelix acetate for depot injection (80mg) Transdermal placebo patch, weekly for 12 weeks
GnRHant + Placebo
GnRH antagonist with placebo add-back
Interventions
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GnRHant + E2
GnRH antagonist with estradiol add-back
GnRHant + Placebo
GnRH antagonist with placebo add-back
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Kerry L Hildreth, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University of Colorado Boulder Intermountain Neuroimaging Consortium
Boulder, Colorado, United States
Countries
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Other Identifiers
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17-0092
Identifier Type: -
Identifier Source: org_study_id
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