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Propranolol for Vascular Responses in Menopause (2100208 Trial)
Phase < 1
Recruiting
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female assigned at birth
Pre, peri- or post-menopausal
Must not have
Male (assigned at birth)
Hysterectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 5 minutes.
Summary
"This trial aims to investigate how blood vessels widen in response to low oxygen levels and the involvement of specific receptors in women of different age groups: younger, middle-aged, and older women."
Who is the study for?
This trial is for women assigned female at birth who are premenopausal, perimenopausal, or postmenopausal. Participants should have a healthy weight with a BMI between 18 and 30 kg/m2. The study aims to understand how aging and menopause affect blood vessel responses during low oxygen conditions.
What is being tested?
The study is testing the effects of Propranolol (a beta-blocker), Gemtesa (used for overactive bladder), and a placebo on blood vessel dilation in hypoxic conditions among different stages of menopause. It's designed to see if these drugs influence the body's response to low oxygen.
What are the potential side effects?
Propranolol may cause dizziness, fatigue, or cold hands/feet. Gemtesa can lead to dry mouth, constipation, or blurred vision. Placebos typically have no active ingredients but can sometimes cause side effects due to psychological factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was assigned female at birth.
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I am before, during, or after menopause.
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My BMI is between 18 and 30.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am biologically male.
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I have had a hysterectomy.
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I have been diagnosed with sleep apnea.
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I have been diagnosed with cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 5 minutes.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 5 minutes.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Forearm blood flow
Trial Design
3Treatment groups
Experimental Treatment
Group I: HypoxiaExperimental Treatment3 Interventions
Participants will be exposed to hypoxia (low oxygen air) using a mask.
Group II: HypercapniaExperimental Treatment3 Interventions
Participants will be exposed to hypercapnia (high carbon dioxide air) using a mask.
Group III: Cold pressor testExperimental Treatment3 Interventions
Participants will be exposed to the cold pressor test (ice water on the foot).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Propranolol
2010
Completed Phase 4
~1290
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
380 Previous Clinical Trials
628,687 Total Patients Enrolled
5 Trials studying Vasodilation
330 Patients Enrolled for Vasodilation