NCT06490146 Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function
| NCT ID | NCT06490146 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Menopause |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2030-08-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-04-01 with a primary completion date of 2030-08-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a longitudinal study to determine the influence of the menopause transition on autonomic and vascular function. PI Keller-Ross has published data demonstrating that postmenopausal females have greater sympathetic neural reactivity during a stressor compared with age-matched males and younger females and males. A paucity of literature exists, however, on the role of the menopause transition in autonomic function because the majority of experimental studies on menopause physiology are cross-sectional and/or focused on older, postmenopausal females . The influence of age on HTN is robust, whereas the effects of menopause are still unclear. Preliminary data demonstrate a clear association between age and sympathetic activity in females; how the transition through menopause influences these relations, however, remains unknown. The study will enroll 80 midlife (45-55 years of age) females to measure longitudinally the trajectory of autonomic and vascular function during the transition through menopause. The study hypothesizes that through the menopause transition, an increase in sympathetic activity and an impaired baroreflex sensitivity and endothelial function will emerge.
Eligibility Criteria
Inclusion Criteria: * Female * age 45-55 years * premenopausal * not using any medications determined to affect autonomic function * eumenorrheic * not planning to become pregnant for the duration of participation in the study * English-speaking, literate, willing and able to provide informed consent. Exclusion Criteria: * Diabetes * pregnant or breastfeeding * cardiac or pulmonary disorders * severe obesity (body mass index \[BMI\] ≥ 40 kg/m 2 ) * hypertension * obstructive sleep apnea * current use of heart or blood pressure medications, current use of hormonal contraceptives or other forms of exogenous sex hormones * report of nicotine/tobacco use in the last six months, report of current alcohol abuse, * history of treatment with chemotherapy/radiation * coagulopathy disorders and/or use of anticoagulant medications, and current use of anxiolytics and/or antidepressants.
Contact & Investigator
Manda Keller-Ross
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06490146 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 55 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06490146 currently recruiting?
Yes, NCT06490146 is actively recruiting participants. Contact the research team at menopause@umn.edu for enrollment information.
Where is the NCT06490146 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06490146 clinical trial?
NCT06490146 is sponsored by University of Minnesota. The principal investigator is Manda Keller-Ross at University of Minnesota. The trial plans to enroll 100 participants.