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Neurovascular Responses to Hot Flashes

N/A
Recruiting
Led By Sarah Baker, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not taking medications influencing cardiovascular function
Free from cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how hot flashes affect women's risk for cardiovascular disease.

Who is the study for?
This trial is for non-obese women who are not on cardiovascular medications, have at least one ovary, do not smoke, and are free from cardiovascular diseases. It aims to understand the connection between hot flashes during menopause and risks of hypertension.
What is being tested?
The study tests how substances like Norepinephrine affect blood vessels and heart function in women with hot flashes. It looks at body responses to stressors and drugs that influence blood pressure and flow during menopausal changes.
What are the potential side effects?
Possible side effects may include changes in blood pressure or heart rate due to Norepinephrine or other agents used. Participants might also experience discomfort from sympathoexcitatory stressors applied during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not on any medications that affect heart function.
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I do not have any heart diseases.
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I have at least one ovary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compare microvascular function in women with low and high frequency hot flashes
Compare sympathetic function in women with low and high frequency hot flashes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: Healthy Women VolunteersExperimental Treatment5 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium Nitroprusside
2018
Completed Phase 1
~240
Norepinephrine
2014
Completed Phase 4
~1780
Terbutaline
2008
Completed Phase 1
~270
Acetylcholine
2013
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,360 Previous Clinical Trials
3,065,821 Total Patients Enrolled
3 Trials studying Menopause
798 Patients Enrolled for Menopause
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,171,998 Total Patients Enrolled
3 Trials studying Menopause
251 Patients Enrolled for Menopause
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,823 Total Patients Enrolled
12 Trials studying Menopause
122,955 Patients Enrolled for Menopause
Sarah Baker, PhDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Menopause
30 Patients Enrolled for Menopause
Michael Joyner, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials

Media Library

Norepinephrine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05193968 — N/A
Menopause Research Study Groups: Experimental: Healthy Women Volunteers
Menopause Clinical Trial 2023: Norepinephrine Highlights & Side Effects. Trial Name: NCT05193968 — N/A
Norepinephrine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05193968 — N/A
~29 spots leftby Dec 2025