MenopauseNCT06490146
Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function
An observational study of Menopause, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 21 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Diabetes
- pregnant or breastfeeding
- cardiac or pulmonary disorders
- severe obesity (body mass index [BMI] ≥ 40 kg/m 2 )
- hypertension
- obstructive sleep apnea
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Emma Lee, menopause@umn.edu
About this study
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
- Being tested
- No intervention
- Keywords
- blood pressure, perimenopause, vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Study group | premenopausal women without vasomotor symptoms (VMS) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSNA- Burst frequency
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 they will attend such visits every six months.
Measured: up to 5 years
MSNA- Burst incidence
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 point they will attend such visits every six months.
Measured: up to 5 years
MSNA- total activity
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 such visits every six months.
Measured: up to 5 years
Secondary outcomes (3)
cardiovagal baroreflex sensitivity: ms/mmHg
Cardiovagal baroreflex is estimated by responses in the R-R interval of the ECG to changes in systolic pressure.
Participants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.
Measured: up to 5 years
sympathetic baroreflex sensitivity: bursts/100heartbeats/mmHg
Sympathetic baroreflex is estimated by responses in MSNA to changes in diastolic pressure.
Participants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.
Measured: up to 5 years
vascular conductance (mL/100mL tissue/min/mmHg)
vascular conductance via venous occlusion plethysmography will be quantified by FBF/mean arterial pressure
Participants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Apr 2025
- Primary completion21 Aug 2030 (estimated)
- Study completion21 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manda Keller-Ross, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490146
- Sponsor's protocol ID
- PT-2024-32769
- Status last verified
- May 2026
- First submitted
- 28 Jun 2024
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function
- ClinicalTrials.gov ID
- NCT06490146
- Acronym / sponsor ID
- PT-2024-32769
- Conditions
- Menopause
- Keywords
- blood pressure, perimenopause, vascular
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 21 Aug 2030 (estimated)
- Study completion
- 21 Aug 2030 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: No interventionpremenopausal women without vasomotor symptoms (VMS) |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- Female
- age 45-55 years
- premenopausal
- not using any medications determined to affect autonomic function
- eumenorrheic
Key exclusion criteria (10 listed)
- Diabetes
- pregnant or breastfeeding
- cardiac or pulmonary disorders
- severe obesity (body mass index [BMI] ≥ 40 kg/m 2 )
- hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionthis is an observational study | Other | Study group |
Primary outcome
MSNA- Burst frequency
Time frame: up to 5 years
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 they will attend such visits every six months.
MSNA- Burst incidence
Time frame: up to 5 years
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 point they will attend such visits every six months.
MSNA- total activity
Time frame: up to 5 years
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 such visits every six months.
3 secondary outcomes
cardiovagal baroreflex sensitivity: ms/mmHg
Time frame: up to 5 years
sympathetic baroreflex sensitivity: bursts/100heartbeats/mmHg
Time frame: up to 5 years
vascular conductance (mL/100mL tissue/min/mmHg)
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manda Keller-Ross principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Lee, PhD (612-301-8617, menopause@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSNA- Burst frequency (time frame: up to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.