Trial · Interventional
Active, not recruitingPhase 4Registry dataOvarian Hormone Regulation of Central and Cerebrovascular Hemodynamics (NoMEN Study)
Overview
- Status
- Active, not recruiting
- Phase
- Phase 4
- Enrollment
- 55 participants (estimated)
- Sponsor
- University of Colorado, Denver · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 22 Nov 2021
- Primary completion
- 18 Sept 2024
- Completion
- 28 Jul 2025 (estimated)
- First posted
- 27 Sept 2021
- Last update posted
- 27 Mar 2025
- Conditions
- Menopause · Estrogen Deficiency · Women · Aging
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics (NoMEN Study)
NCT0505754622 Nov 2021 to est. 28 Jul 2025
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- GnRH antagonistDrug
Arms1
Experimental
Premenopausal Group: GnRH antagonist
Gonadotropin releasing hormone (GnRH) antagonist is degarelix acetate, 80 mg, delivered once as a subcutaneous injection.
Primary outcomes1
Outcomes the sponsor listed as primary.
Aortic stiffness and pulsatile hemodynamics
Time frame · Change from baseline at 12 weeks
Registry description
Aortic characteristic impedance and forward pressure wave amplitude
Secondary outcomes(4)
Common carotid artery stiffness and pulsatile hemodynamics
Time frame · Change from baseline at 12 weeks
Registry description
Carotid characteristic impedance and forward pressure wave amplitude
Macrovascular cerebral blood flow
Time frame · Change from baseline at 12 weeks
Registry description
Cerebral blood flow measured by transcranial Doppler
Macrovascular cerebrovascular reserve
Time frame · Change from baseline at 12 weeks
Registry description
Breath hold index measured by transcranial Doppler
Microvascular cerebral blood flow
Time frame · Change from baseline at 12 weeks
Registry description
Cerebral blood flow measured by Arterial Spin Labeling Magnetic Resonance Imaging
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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