Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics (NoMEN Study)
NCT05057546 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2025-03-27
Summary
This study will evaluate changes in blood vessels around the heart (e.g., aorta and carotid arteries) and in the brain with the loss of female sex hormones (e.g., estrogen) during the menopause transition. The menopause transition is associated with declines in blood vessel function and increased risk for cardiovascular disease and Alzheimer's disease. Increasing evidence supports an early role for declines in blood vessel function and future development of Alzheimer's disease in aging men and women. This study will learn about the effects of changes in female sex hormones, such as estrogen, during the menopause transition on blood vessel around the heart and in the brain in women.
Conditions
- Menopause
- Estrogen Deficiency
- Women
- Aging
Interventions
- DRUG
-
GnRH antagonist
GnRH antagonist will be given once for premenopausal women (12-week intervention) and twice for postmenopausal women (24-week intervention)
Sponsors & Collaborators
-
University of Colorado, Denver
lead OTHER
Principal Investigators
-
Lyndsey DuBose, PhD · University of Colorado Denver Anschutz Medical Campus
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-11-22
- Primary Completion
- 2024-09-18
- Completion
- 2025-07-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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