Brain Blood Flow Responses to Stress: Sex Differences

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT06253702
Phase
PHASE4
Status
Completed

Conditions

  • Cerebrovascular Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Indomethacin — DRUG
    to inhibit cyclooxygenase (COX)
  • Placebo — DRUG
    Placebo
  • Orilissa — DRUG
    to suppress hormones 200mg dose 2x per day (all participants)
  • Testosterone gel — DRUG
    50 mg each morning for add back phase (male participants)
  • Anastrozole — DRUG
    1mg/day in men to prevent conversion of testosterone to estradiol
  • Estradiol — DRUG
    Women will receive oral estradiol 2mg/daily

Study Details

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.

Key Dates

Start date
Jul 24, 2024
Status verified
Jul 2025
Primary completion
May 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Placebo First: Hormone Suppression
    Participants drug (placebo vs Indo) are randomized prior to first set of MRI visits, while experiencing hormone suppression.
  • Experimental: Indo First: Hormone Suppression
    Participants drug (placebo vs Indo) are randomized prior to first set of MRI visits, while experiencing hormone suppression.
  • Experimental: Placebo First: Hormone Add-Back
    Participants drug (placebo vs Indo) are randomized prior to second set of MRI visits, while experiencing hormone add-back.
  • Experimental: Indo First: Hormone Add-Back
    Participants drug (placebo vs Indo) are randomized prior to second set of MRI visits, while experiencing hormone add-back.

Primary Outcome Measure

Cerebral Blow Flow (CBF): Hormone Suppression Hypoxia Condition [ Time Frame: first set of study visits (up to 2 hours) within the first 7 days on study ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53705-

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By research site
University of Wisconsin· Madison, WI

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