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

NCT05057546 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 21-3590
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Aortic stiffness and pulsatile hemodynamics

  Aortic characteristic impedance and forward pressure wave amplitude

  Change from baseline at 12 weeks

Secondary Outcomes (4)

• Common carotid artery stiffness and pulsatile hemodynamics

  Change from baseline at 12 weeks

• Macrovascular cerebral blood flow

  Change from baseline at 12 weeks

• Macrovascular cerebrovascular reserve

  Change from baseline at 12 weeks

• Microvascular cerebral blood flow

  Change from baseline at 12 weeks

Study Arms (1)

Premenopausal Group: GnRH antagonist

EXPERIMENTAL

Gonadotropin releasing hormone (GnRH) antagonist is degarelix acetate, 80 mg, delivered once as a subcutaneous injection.

Drug: GnRH antagonist

Interventions

GnRH antagonist DRUG

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

Also known as: Degarelix acetate

Premenopausal Group: GnRH antagonist

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Study Officials

• Lyndsey DuBose, PhD

  University of Colorado Denver Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: BESH clinical trial

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 27, 2021
• Study Start: November 22, 2021
• Primary Completion: September 18, 2024
• Study Completion: July 28, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)