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Hormone Effects on Brain Blood Flow

Phase 4
Recruiting
Led By William G Schrage, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between ≥18 - ≤40 years inclusive
Be between 18 and 65 years old
Must not have
Current diagnosis or history of hepatic disease
Current diagnosis or history of lung disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up second set of study visits (up to 2 hours) within 12-16 days on study
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will involve 26 healthy adults aged 18-40 to understand how sex and sex hormones affect blood flow in the brain. The study will last around 16 days.

Who is the study for?
This trial is for healthy adults aged 18-40 who want to help understand how sex and hormones affect brain blood flow. The study will include an equal number of males and females, totaling 26 participants.
What is being tested?
The study tests the effects of testosterone gel, placebo, Anastrozole (blocks estrogen production), Orilissa (alters hormone levels), Indomethacin (a pain reliever), and Estradiol (a form of estrogen) on brain blood flow in response to stress.
What are the potential side effects?
Possible side effects may include skin reactions at the gel application site, hormonal changes like mood swings or irregular periods, headache from Indomethacin, and other individual responses to hormone alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had liver disease.
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I have or had lung disease.
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I have or had stomach or intestinal problems that caused bleeding.
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I have or had peripheral vascular disease.
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I have or had kidney disease.
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I have been diagnosed with or have a history of prediabetes.
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I have been diagnosed with diabetes.
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I have been diagnosed with sleep apnea.
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I have been diagnosed with high blood pressure.
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I have a condition affecting my menstrual cycle.
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I have been diagnosed with polycystic ovary syndrome.
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I have or had a blood disorder.
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I have had a stroke or currently have one.
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I have had a heart attack before.
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I have or had coronary heart disease.
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I have or had congestive heart failure.
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I have had heart surgery or have been diagnosed with a heart condition.
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I am a woman with excessive hair growth on my face, chest, or back.
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I am using a levonorgestrel IUD for birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~second set of study visits (up to 2 hours) within 12-16 days on study
This trial's timeline: 3 weeks for screening, Varies for treatment, and second set of study visits (up to 2 hours) within 12-16 days on study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cerebral Blow Flow (CBF): Hormone Suppression Hypoxia Condition
Cerebral Blow Flow: Hormone Add-Back Hypercapnia Condition
Cerebral Blow Flow: Hormone Add-Back Hypoxia Condition
+1 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Placebo First: Hormone SuppressionExperimental Treatment4 Interventions
Participants drug (placebo vs Indo) are randomized prior to first set of MRI visits, while experiencing hormone suppression.
Group II: Placebo First: Hormone Add-BackExperimental Treatment6 Interventions
Participants drug (placebo vs Indo) are randomized prior to second set of MRI visits, while experiencing hormone add-back.
Group III: Indo First: Hormone SuppressionExperimental Treatment3 Interventions
Participants drug (placebo vs Indo) are randomized prior to first set of MRI visits, while experiencing hormone suppression.
Group IV: Indo First: Hormone Add-BackExperimental Treatment6 Interventions
Participants drug (placebo vs Indo) are randomized prior to second set of MRI visits, while experiencing hormone add-back.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indomethacin
2011
Completed Phase 4
~5790
Placebo
1995
Completed Phase 3
~2670
Testosterone gel
2018
Completed Phase 4
~930
Anastrozole
2016
Completed Phase 4
~5550
Estradiol
2008
Completed Phase 4
~3960

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,232 Previous Clinical Trials
3,200,021 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,792,271 Total Patients Enrolled
William G Schrage, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
2 Previous Clinical Trials
30 Total Patients Enrolled
~4 spots leftby Mar 2025
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