Human Cerebral Blood Flow Regulation

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

April 12, 2021

Primary Completion Date

March 31, 2025

Study Completion Date

May 31, 2025

Conditions
Cerebral Arterial Diseases
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.

DRUG

Ganirelix Acetate

"Gonadotropin-Releasing Hormone (GnRH) antagonist ganirelix acetate as a model to isolate estrogen and testosterone effects on the cerebrovascular system. Participants receive daily injections of ganirelix for 12-14 days for Aim 3 studies only. This will be overseen by clinical endocrinologists.~Both males and females receive this treatment in Aim 3."

DRUG

Testosterone Transdermal Product

In Aim 3, males receive this for 7-9 days of the ganirelix treatment.

DRUG

Estradiol Topical

In Aim 3, females receive this for 7-9 days of the ganirelix treatment.

DRUG

Antacid

Participants will be given a dose of over-the-counter antacid to combat the gastrointestinal distress expected from Indomethacin. Participants will be given a dose of over-the-counter antacid during the placebo visit to mimic the indomethacin study visit. Antacid is IND exempt.

Trial Locations (1)

53706

University of Wisconsin, Madison, Madison

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of Wisconsin, Madison

OTHER