Recruiting

Menopause Transition

Sponsor:

University of Minnesota

Code:

NCT06490146

Conditions

Menopause

Eligibility Criteria

Sex: Female

Age: 45 - 55

Healthy Volunteers: Accepted

Interventions

No intervention

Study Details

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.

Conditions

Menopause

Study ID

NCT06490146

Start date

Apr 1, 2025

Status verified date

May, 2026

Completion date

Aug 21, 2030

Anticipated

Primary completion date

Aug 21, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Study group

premenopausal women without vasomotor symptoms (VMS)

Interventions

No intervention

this is an observational study

Primary outcome measure

  • MSNA- Burst frequency [ Time Frame: up to 5 years ]
  • MSNA- Burst incidence [ Time Frame: up to 5 years ]
  • MSNA- total activity [ Time Frame: up to 5 years ]

Central Contacts and Locations

Central contacts

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

More Information

Sponsor

University of Minnesota

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

  • blood pressure
  • perimenopause
  • vascular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-05-20.