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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

Study 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.Check my eligibility

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.See study design

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 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)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compare microvascular function in women with low and high frequency hot flashes

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

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

Norepinephrine

2014

Completed Phase 4

~1780

Sodium Nitroprusside

2018

Completed Phase 1

~220

Terbutaline

2008

Completed Phase 1

~270

Acetylcholine

2013

Completed Phase 2

~220

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,766,918 Total Patients Enrolled

2 Trials studying Menopause

768 Patients Enrolled for Menopause

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,756 Total Patients Enrolled

3 Trials studying Menopause

251 Patients Enrolled for Menopause

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,837 Previous Clinical Trials

47,851,474 Total Patients Enrolled

12 Trials studying Menopause

122,955 Patients Enrolled for Menopause

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly participants sought after in this research endeavor?

"This research project is only open to patients between the ages of 45-55. However, there are 8 trials for minors and 55 studies available for those over 65 years old."

Answered by AI

To what extent is this clinical trial being populated by participants?

"Affirmative. Information on clinicaltrials.gov seems to indicate that this medical experiment is currently enrolling patients; the trial was first posted on February 24th 2022 and most recently edited on March 14th 2022. The research team requires 120 individuals from 1 site for their study."

Answered by AI

Are there any still vacancies in this clinical investigation?

"As per clinicaltrials.gov, this ongoing research is actively recruiting participants from the time of its initial posting on February 24th 2022 to its latest revision on March 14th 2022."

Answered by AI

Could I be considered a candidate for the clinical experiment?

"This clinical trial is enrolling 120 adults aged 45-55 experiencing hot flashes. To qualify, applicants must have at least one ovary and cannot be smokers, obese or taking any drugs that might affect cardiovascular function. In addition, they need to be free from any existing cardiovascular conditions"

Answered by AI

Have there been previous experiments involving this particular therapeutic approach?

"Presently, 29 investigations of this particular treatment are underway. 5 of these ongoing clinical trials have advanced to Phase 3. The primary research centres for most of the studies can be found in Salt Lake City, Utah though there remain 50 locations running relevant experiments."

Answered by AI

What is the usual indication for this therapeutic regimen?

"This therapeutic approach is effective at managing hypotension, preventing preterm labour, and alleviating the symptoms of chronic obstructive airway disease."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?

Did not meet criteria

Why did patients apply to this trial?

I just started having hot flashes and I really want to figure out how I can help myself and other women. I don’t feel there is enough information out there for women.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

Hot Flashes and Neurovascular Function in Women

Sarah E. Baker, Ph.D. 2022. "Hot Flashes and Neurovascular Function in Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05193968.

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