Brain Blood Flow Responses to Stress: Sex Differences

Summary

Twenty-six otherwise healthy adults between 18-40 years of age composed of 13 males and 13 females will be enrolled in this study to determine how sex and sex hormones influence cerebral blood flow (CBF) control in healthy young adults without confounds of age or disease. Participants can expect to be on study for approximately 16 days.

Conditions

• Cerebrovascular Disorders

Interventions

DRUG

Indomethacin

to inhibit cyclooxygenase (COX)

DRUG

Placebo

Placebo

DRUG

Orilissa

to suppress hormones 200mg dose 2x per day (all participants)

DRUG

Testosterone gel

50 mg each morning for add back phase (male participants)

DRUG

Anastrozole

1mg/day in men to prevent conversion of testosterone to estradiol

DRUG

Estradiol

Women will receive oral estradiol 2mg/daily

Sponsors & Collaborators

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

  collaborator NIH

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• William G Schrage, PhD · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-24

Primary Completion

2025-05-31

Completion

2025-05-31

FDA Drug

Yes

Countries

• United States

Study Locations