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

NCT ID: NCT05057546

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-22
• Study Completion Date: 2025-07-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Premenopausal Group: GnRH antagonist

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

Group Type: EXPERIMENTAL

GnRH antagonist

Intervention Type: DRUG

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

Interventions

GnRH antagonist

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

Intervention Type: DRUG

Other Intervention Names

Degarelix acetate

Eligibility 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;
• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndsey DuBose, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver Anschutz Medical Campus

Locations

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

21-3590

Identifier Type: -

Identifier Source: org_study_id