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Trial · Interventional

Active, not recruitingPhase 4Registry data

Ovarian 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
202120222023202420252026
  1. Ph 4

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

    NCT05057546

    22 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.

  1. 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)
  1. 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

  2. Macrovascular cerebral blood flow

    Time frame · Change from baseline at 12 weeks

    Registry description

    Cerebral blood flow measured by transcranial Doppler

  3. Macrovascular cerebrovascular reserve

    Time frame · Change from baseline at 12 weeks

    Registry description

    Breath hold index measured by transcranial Doppler

  4. 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
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: * 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; * Plasma glucose \>126 mg/dl under fasting conditions; * Smoking or living with a smoker within the past 12 months; * Current or planned participation in an interventional study during the present study or unwillingness to complete study-related procedures; * Patients who report active acute systemic infection (e.g., flu, common cold, etc), fever (\> 100.0 °F) or feeling ill will be asked to delay vascular testing until they are no longer febrile or ill. Additionally, anyone who has experienced a serious illness (requiring hospitalization) within the last 6 months, had a confirmed positive COVID test and hospitalized, or anyone with a confirmed positive COVID test within the last 6 months will be ineligible to participate (discretion of the study PI and MD). * No use of vitamin/supplements or chronic use of anti-inflammatory medications, or willingness to stop 1 month prior to the vascular visit. In premenopausal women participating in the intervention: * Contraindications to Degarelix including hypersensitivity to degarelix acetate, extrinsic peptide hormones, mannitol, GnRH, benzyl alcohol (the vehicle for injection of degarelix acetate) * Undiagnosed vaginal bleeding * Osteopenia or osteoporosis (i.e., proximal femur or lumbar spine DXA Z scores \<-1.0) * CES-D score ≥16 (unless clinician follow-up and clinical judgement determine they are eligible (will be noted in study chart)

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