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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premenopausal Group: GnRH antagonist | Experimental | Gonadotropin releasing hormone (GnRH) antagonist is degarelix acetate, 80 mg, delivered once as a subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH antagonist | Drug | GnRH antagonist will be given once for premenopausal women (12-week intervention) and twice for postmenopausal women (24-week intervention) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aortic stiffness and pulsatile hemodynamics | Aortic characteristic impedance and forward pressure wave amplitude | Change from baseline at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Common carotid artery stiffness and pulsatile hemodynamics | Carotid characteristic impedance and forward pressure wave amplitude | Change from baseline at 12 weeks |
| Macrovascular cerebral blood flow |
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Inclusion Criteria: Healthy premenopausal, early perimenopausal and postmenopausal women will be recruited. Premenopausal women will have regular menstrual cycles, with no change in observed cycle length (21-35 days), confirmed by menstrual cycle calendars. Early perimenopausal will be defined as a change in cycle length of >7 days from normal with no skipped periods and/or a FSH <25 IU/L (with discretion of the study MD). Postmenopausal women will have gone through natural (i.e., non-surgical) menopause with >12 months but <6 years of amenorrhea. We will make a major effort to ensure that the women enrolled in this study come from all races and ethnicities and a wide range of socioeconomic and educational levels.
Exclusion Criteria:
In premenopausal women participating in the intervention:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndsey DuBose, PhD | University of Colorado Denver Anschutz Medical Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 4, 2025 | |
| Reset | Aug 21, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 4, 2025 | Aug 21, 2025 | |||
| Aug 25, 2025 |
| ID | Term |
|---|---|
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
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BESH clinical trial
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|
Cerebral blood flow measured by transcranial Doppler
| Change from baseline at 12 weeks |
| Macrovascular cerebrovascular reserve | Breath hold index measured by transcranial Doppler | Change from baseline at 12 weeks |
| Microvascular cerebral blood flow | Cerebral blood flow measured by Arterial Spin Labeling Magnetic Resonance Imaging | Change from baseline at 12 weeks |
| Sep 10, 2025 |
| 9 |
| Sep 23, 2025 | Sep 24, 2025 | 10 |