Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function

What this trial studies

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.

Conditions in scope

• Menopause

Interventions

• No intervention (Other) — this is an observational study

Who can join

Women only · Ages 45 Years to 55 Years · Accepts healthy volunteers.

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,

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2025-04-01
• Primary completion: 2030-08-21
• Last update posted: 2025-05-08
• First posted: 2024-07-08

Sponsor & contact

Lead sponsor: University of Minnesota (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• MSNA- Burst frequency (up to 12 months)
  measured in bursts/min Microneurography to measure MSNA: Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves. A tungsten microelectrode is placed in a peripheral nerve (Figure 8) to record real-time activity from efferent sympathetic vasoconstrictor nerve fibers. MSNA is the gold-standard measure for sympathetic activity Participants attend experimental visits annually until they enter perimenopause, at which point…
• MSNA- Burst incidence (up to 12 months)
  measured in bursts/100 heartbeats Microneurography to measure MSNA: Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves. A tungsten microelectrode is placed in a peripheral nerve (Figure 8) to record real-time activity from efferent sympathetic vasoconstrictor nerve fibers. MSNA is the gold-standard measure for sympathetic activity Participants attend experimental visits annually until they enter perimenopause, at which…
• MSNA- total activity (up to 12 months)
  Microneurography to measure MSNA: Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves. A tungsten microelectrode is placed in a peripheral nerve (Figure 8) to record real-time activity from efferent sympathetic vasoconstrictor nerve fibers. MSNA is the gold-standard measure for sympathetic activity Participants attend experimental visits annually until they enter perimenopause, at which point they will attend…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.