Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics (NoMEN Study)

What this trial studies

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 in scope

• Menopause
• Estrogen Deficiency
• Women
• Aging

Interventions

• GnRH antagonist (Drug) — GnRH antagonist will be given once for premenopausal women (12-week intervention) and twice for postmenopausal women (24-week intervention)

Who can join

Women only · Ages 18 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• See ClinicalTrials.gov for full inclusion criteria.

Exclusion criteria

• Seated resting blood pressure \>140/90 mmHg
• Use of medications that might influence cardiovascular function or cerebral blood flow;
• Pregnant, currently breastfeeding or intention to become pregnant in the next 6 months;
• Use of menopausal therapy or hormonal contraceptives, etc. within the previous 3 months or intent to start during the study period;
• BMI \>39 kg/m2;
• Vigorous intensity exercise \>2 days per week;
• Any current or past history of systemic illness that would interfere with study outcomes such as: diabetes, cancer (other than melanoma), liver, gallbladder disease, peripheral artery disease or thromboembolism, neurological disease, CVD or cerebrovascular disease;
• Abnormal thyroid, liver, or kidney function testing during the screening examination or bloodwork;

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: PHASE4
• Start date: 2021-11-22
• Primary completion: 2024-09-18
• Last update posted: 2025-03-27
• First posted: 2021-09-27

Sponsor & contact

Lead sponsor: University of Colorado, Denver (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Aortic stiffness and pulsatile hemodynamics (Change from baseline at 12 weeks)
  Aortic characteristic impedance and forward pressure wave amplitude

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.