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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ second set of study visits (up to 2 hours) within 12-16 days on study

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

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

0 / 20Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,210 Previous Clinical Trials

3,157,713 Total Patients Enrolled

15 Trials studying Stroke

271,136 Patients Enrolled for Stroke

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

3,889 Previous Clinical Trials

47,834,181 Total Patients Enrolled

86 Trials studying Stroke

537,431 Patients Enrolled for Stroke

William G Schrage, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

2 Previous Clinical Trials

30 Total Patients Enrolled

~7 spots leftby Mar 2025

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