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COMPLETED
NCT04265053
EARLY_PHASE1

Human Cerebral Blood Flow Regulation

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

Summary

To determine cerebrovascular control mechanisms in humans and provide mechanistic knowledge to offer new sex-specific therapeutic options for cerebrovascular diseases. The current objective is to determine how sex and sex hormones influence CBF control in healthy young adults without confounds of age or disease. The central hypothesis is men exhibit reduced cerebral vasodilator function due in part to differences in COX signaling compared to women. Comprehensive CBF data from multi-modal MRI indicate the magnitude of sex differences-as well as the vasodilator mechanisms-are regionally distinct. Research confounding variables like aging and disease will be mitigated by comparing younger adults (18-40 years old).

Official title: Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2021-04-12

Completion Date

2025-05-31

Last Updated

2026-06-12

Healthy Volunteers

Yes

Interventions

DRUG

Indomethacin 25 MG/50 MG

Indomethacin is a nonsteroidal anti-inflammatory drug commonly used to reduce fever, pain, stiffness, and swelling from inflammation. It prevents the production of prostaglandins, endogenous signaling molecules known to cause symptoms from inflammation. Indomethacin is used to test COX as a potential mechanism explaining sex differences in CBF control. Indomethacin usage is IND exempt.

DRUG

Placebo - Lactose

Participants will be screened for lactose intolerance. Total dosing will be calculated to match the mg needed for the indomethacin study visit. Placebo usage is IND exempt.

Locations (1)

University of Wisconsin, Madison

Madison, Wisconsin, United States