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Indo First: Hormone Add-Back for Stroke

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

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

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 18 and 40 years old.

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

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

Primary outcome measures

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

Testosterone gel

2018

Completed Phase 4

~930

Placebo

1995

Completed Phase 3

~2670

Estradiol

2008

Completed Phase 4

~3960

Indomethacin

2011

Completed Phase 4

~4130

Anastrozole

2019

Completed Phase 4

~10300

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

3,840 Previous Clinical Trials

47,852,098 Total Patients Enrolled

86 Trials studying Stroke

537,505 Patients Enrolled for Stroke

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,505 Total Patients Enrolled

14 Trials studying Stroke

271,120 Patients Enrolled for Stroke

William G Schrage, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

2 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals are enrolled as participants in this ongoing medical study?

"Affirmative. Information from clinicaltrials.gov highlights the ongoing patient recruitment for this study. The trial was initially posted on June 13, 2023 and underwent its latest update on February 2, 2024. A total of 26 participants are sought at a single investigational site."

Answered by AI

Is it possible for patients to enroll in this ongoing clinical trial?

"Yes, the details on clinicaltrials.gov indicate that recruitment is ongoing for this trial. The trial was first listed on June 13th, 2023, and its most recent update was made on February 2nd, 2024. This study aims to enroll a total of 26 participants from one location."

Answered by AI

Which individuals would be considered ideal candidates for participation in this clinical trial?

"Individuals aged between 18 and 40 years old who have experienced a stroke are eligible to participate in this clinical research. The study aims to enroll approximately 26 participants."

Answered by AI

Has Indo First: Hormone Add-Back received approval from the FDA?

"Based on the assessment by our team at Power, Indo First: Hormone Add-Back has been deemed safe with a rating of 3. This determination is due to its Phase 4 status, signifying official approval for this treatment protocol."

Answered by AI

Do participants aged above 85 meet the criteria for inclusion in this medical study?

"Individuals aged between 18 and 40 years are eligible for enrollment in this clinical trial, with no one below the age of majority or above 40 meeting inclusion criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brain Blood Flow Responses to Stress: Sex Differences

2023. "Brain Blood Flow Responses to Stress: Sex Differences". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06253702.

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