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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 belowSelect...
I am not on any medications that affect heart function.
Select...
I do not have any heart diseases.
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I have at least one ovary.
Timeline
Screening ~ 3 weeks3 visits
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)
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)
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
3,333 Previous Clinical Trials
3,060,052 Total Patients Enrolled
2 Trials studying Menopause
768 Patients Enrolled for Menopause
National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,138 Total Patients Enrolled
3 Trials studying Menopause
251 Patients Enrolled for Menopause
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,929 Previous Clinical Trials
47,765,107 Total Patients Enrolled
12 Trials studying Menopause
122,955 Patients Enrolled for Menopause
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on any heart-related medications.You are not overweight.I am not on any medications that affect heart function.N/AI do not have any heart diseases.I have at least one ovary.I do not have any heart diseases.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Healthy Women Volunteers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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