ClinicalTrials.gg
RecruitingNCT05193968Updated Jun 12, 2026

Hot Flashes and Neurovascular Function in Women

An interventional study of Sympathoexcitatory stressors and Sodium Nitroprusside in Hot Flashes, Menopause and Vasomotor System; Labile, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to female participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Feb 2022; still recruiting 4 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
40 Years to 60 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Hot Flashes
  • Menopause
  • Vasomotor System; Labile

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Keywords

  • Neurovascular function
  • Autonomic function
  • Microvascular Function
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In context

Hot Flashes

339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.

This study's planned enrollment of 120 is above the median of 90 across 306 interventional studies indexed under Hot Flashes.

Browse Hot Flashes studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Non-smokers.
  • Non-obese.
  • Have at least one ovary.
  • Free from cardiovascular disease.
  • Not taking medications influencing cardiovascular function.

Exclusion criteria

Exclusion Criteria:

- None.

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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Other
    Experimental: Healthy Women Volunteers

    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

    Other: Sympathoexcitatory stressors · Drug: Sodium Nitroprusside · Drug: Acetylcholine · Drug: Terbutaline · Drug: Norepinephrine

Interventions

  • OtherSympathoexcitatory stressors

    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.

    Also known as: Valsalva maneuver, handgrip exercise, ice water, and hypercapnia

  • 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.

    Also known as: Forearm vascular conductance response to sodium nitroprusside

  • 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

    Also known as: Forearm vascular conductance response to acetylcholine

  • 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.

    Also known as: Forearm vascular conductance response to terbutaline

  • 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

    Also known as: Forearm vascular conductance response to norepinephrine

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What researchers measure

Primary outcomes

  1. 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

    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)

  2. Compare sympathetic function in women with low and high frequency hot flashes

    Muscle Sympathetic Nerve Activity will be directly using a technique called microneurography.

    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)

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Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    Recruiting
    • Pamela A Engrav · Contact507-255-6938
    • Nancy J Meyer · Contact507-255-0913
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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05193968
Lead sponsor
Mayo Clinic
Responsible party
Sarah E. Baker, Ph.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 18, 2022
Start date
Feb 24, 2022
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 12, 2026

Study contacts

Pamela A Engrav
Contact
engrav.pamela@mayo.edu
507-255-6938
Nancy J Meyer
Contact
meyer.nancy2@mayo.edu
507-255-0913
Sarah Baker, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Nitroprusside · Acetylcholine · Terbutaline · Norepinephrine

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