Hot FlashesNCT05193968
Hot Flashes and Neurovascular Function in Women
A study testing Sympathoexcitatory stressors, Sodium Nitroprusside and Acetylcholine in people with Hot Flashes and Menopause, run by Mayo Clinic at 1 site in United States.
Trial summary
Women who experience hot flashes are at greater risk for hypertension and other cardiovascular disease. Neurovascular control mechanisms are likely to play an important role in this relationship. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes, Menopause, Vasomotor System; Labile
- What is being tested?
- Sympathoexcitatory stressors, Sodium Nitroprusside and Acetylcholine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2022to Dec 2026
- Phase
- Interventional
- 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smokers.
- Non-obese.
- Have at least one ovary.
- Free from cardiovascular disease.
- Not taking medications influencing cardiovascular function.
Who cannot join
- None.
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
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Pamela A Engrav, 507-255-6938
Nancy J Meyer, 507-255-0913
About this study
Women who experience hot flashes are at greater risk for hypertension and other cardiovascular disease. Neurovascular control mechanisms are likely to play an important role in this relationship. As such, these studies are designed to provide a major step forward in understanding the link between hot flashes and neurovascular dysfunction and, by extension, cardiovascular disease in women.
- Conditions
- Hot Flashes, Menopause, Vasomotor System; Labile
- Being tested
- Sympathoexcitatory stressors, Sodium Nitroprusside, Acetylcholine, Terbutaline, Norepinephrine
- Keywords
- Neurovascular function, Autonomic function, Microvascular Function
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sympathoexcitatory stressorsOther
Also called Valsalva maneuver, handgrip exercise, ice water, and hypercapnia
Muscle sympathetic nerve activity will be measured continuously at baseline and in response to sympathoexcitatory stressors, including a Valsalva maneuver, isometric handgrip exercise, a cold pressor test, and stepped hypercapnia.
Sodium NitroprussideDrug
Also called Forearm vascular conductance response to sodium nitroprusside
Sodium nitroprusside, used to test endothelium-independent vasodilation, will be infused through a brachial artery catheter at 0.25, 0.5, 1.0 and 2.0 ug/100ml tissue/min.
AcetylcholineDrug
Also called Forearm vascular conductance response to acetylcholine
Acetylcholine, used to test endothelium-dependent vasodilation, will be infused through a brachial artery catheter at 1.0, 2.0, 4.0, and 8.0 μg/100ml tissue/min
TerbutalineDrug
Also called Forearm vascular conductance response to terbutaline
Terbutaline, a β2-Adrenergic selective agonist, will be infused through a brachial artery catheter at 0.1, 0.5, 1.0, and 2.0 μg/100ml tissue/min.
NorepinephrineDrug
Also called Forearm vascular conductance response to norepinephrine
Norepinephrine, an α-adrenergic vasoconstricting agent, will be infused through a brachial artery catheter at 1.0, 2.0, 4.0, and 8.0 ng/100ml tissue/min
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Healthy Women Volunteers | Other | Hot Flash frequency will be assessed in the study subjects during a screening period. Participants can then chose to participate 1 or 2 study visits- Protocol 1: Microvascular function and/or Protocol 2: Autonomic function Receives: Other: Sympathoexcitatory stressors; Drug: Sodium Nitroprusside; Drug: Acetylcholine; Drug: Terbutaline; Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare microvascular function in women with low and high frequency hot flashes
Change in forearm vascular conductance with intra-arterial drug infusions.
Vascular conductance is an index of vascular tone and is assessed using a technique called venous occlusion plethysmography
Measured: Continuous measurement of vascular conductance during infusion of each drug- 3min at baseline and at each drug dose (~60min total of continuous forearm vascular conductance measurements)
Compare sympathetic function in women with low and high frequency hot flashes
Muscle Sympathetic Nerve Activity will be directly using a technique called microneurography.
Measured: Continuous measurement of muscle sympathetic nerve activity at rest and in response to stressors (~75min of continuous data collection once a sympathetic nerve signal is found)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start24 Feb 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sarah E. Baker, Ph.D., Mayo Clinic
- Investigators
- Sarah Baker, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193968
- Sponsor's protocol ID
- 19-002638
- Other IDs
- K01HL148144
- Status last verified
- Jun 2026
- First submitted
- 15 Nov 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hot Flashes and Neurovascular Function in Women
- ClinicalTrials.gov ID
- NCT05193968
- Acronym / sponsor ID
- 19-002638
- Conditions
- Hot Flashes, Menopause, Vasomotor System; Labile
- Keywords
- Neurovascular function, Autonomic function, Microvascular Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Jan 2022 (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.
Women who experience hot flashes are at greater risk for hypertension and other cardiovascular disease. Neurovascular control mechanisms are likely to play an important role in this relationship. As such, these studies are designed to provide a major step forward in understanding the link between hot flashes and neurovascular dysfunction and, by extension, cardiovascular disease in women.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Healthy Women Volunteers | Other | Other: Sympathoexcitatory stressors, Drug: Sodium Nitroprusside, Drug: Acetylcholine, Drug: Terbutaline, Drug: NorepinephrineHot Flash frequency will be assessed in the study subjects during a screening period. Participants can then chose to participate 1 or 2 study visits- Protocol 1: Microvascular function and/or Protocol 2: Autonomic function |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smokers.
- Non-obese.
- Have at least one ovary.
- Free from cardiovascular disease.
- Not taking medications influencing cardiovascular function.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Sympathoexcitatory stressorsAlso: Valsalva maneuver, handgrip exercise, ice water, and hypercapniaMuscle sympathetic nerve activity will be measured continuously at baseline and in response to sympathoexcitatory stressors, including a Valsalva maneuver, isometric handgrip exercise, a cold pressor test, and stepped hypercapnia. | Other | Experimental: Healthy Women Volunteers |
| Sodium NitroprussideAlso: Forearm vascular conductance response to sodium nitroprussideSodium nitroprusside, used to test endothelium-independent vasodilation, will be infused through a brachial artery catheter at 0.25, 0.5, 1.0 and 2.0 ug/100ml tissue/min. | Drug | Experimental: Healthy Women Volunteers |
| AcetylcholineAlso: Forearm vascular conductance response to acetylcholineAcetylcholine, used to test endothelium-dependent vasodilation, will be infused through a brachial artery catheter at 1.0, 2.0, 4.0, and 8.0 μg/100ml tissue/min | Drug | Experimental: Healthy Women Volunteers |
| TerbutalineAlso: Forearm vascular conductance response to terbutalineTerbutaline, a β2-Adrenergic selective agonist, will be infused through a brachial artery catheter at 0.1, 0.5, 1.0, and 2.0 μg/100ml tissue/min. | Drug | Experimental: Healthy Women Volunteers |
| NorepinephrineAlso: Forearm vascular conductance response to norepinephrineNorepinephrine, an α-adrenergic vasoconstricting agent, will be infused through a brachial artery catheter at 1.0, 2.0, 4.0, and 8.0 ng/100ml tissue/min | Drug | Experimental: Healthy Women Volunteers |
Primary outcome
Compare microvascular function in women with low and high frequency hot flashes
Time frame: Continuous measurement of vascular conductance during infusion of each drug- 3min at baseline and at each drug dose (~60min total of continuous forearm vascular conductance measurements)
Change in forearm vascular conductance with intra-arterial drug infusions. Vascular conductance is an index of vascular tone and is assessed using a technique called venous occlusion plethysmography
Compare sympathetic function in women with low and high frequency hot flashes
Time frame: Continuous measurement of muscle sympathetic nerve activity at rest and in response to stressors (~75min of continuous data collection once a sympathetic nerve signal is found)
Muscle Sympathetic Nerve Activity will be directly using a technique called microneurography.
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 12 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hot Flashes
Not yet recruiting
Internet-Delivered CBT Program for Menopausal Vasomotor Symptoms
Menopause, Menopausal Vasomotor Symptoms
Not yet recruiting
Self-Management Box on Hot Flash in Postmenopausal Women
Postmenopausal Flushing, Postmenopausal Symptoms
Recruiting
Effects of a Dietary Supplement in Women With Late Perimenopause or Early Postmenopause
Perimenopause, Postmenopause
RecruitingPhase 2
Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
Vasomotor Symptoms
RecruitingPhase 4
The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
Obesity, Menopause Hot Flashes
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.
Sarah Baker, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sympathoexcitatory stressors, Sodium Nitroprusside and Acetylcholine in people with Hot Flashes and Menopause, run by Mayo Clinic 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 5 inclusion and 1 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 12 Jun 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 Pamela A Engrav (507-255-6938, engrav.pamela@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare microvascular function in women with low and high frequency hot flashes (time frame: Continuous measurement of vascular conductance during infusion of each drug- 3min at baseline and at each drug dose (~60min total of continuous forearm vascular conductance measurements)). The study lists 2 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 12 Jun 2026.