Sex hormones may hold the key to brain blood flow control
NCT ID NCT06253702
First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time
Summary
Researchers at the University of Wisconsin, Madison, are studying how sex and sex hormones influence the way blood flows in the brain. They enroll 22 healthy adults aged 18 to 40, half male and half female. Participants take hormones to suppress their natural sex hormones, then add them back, while MRI scans measure brain blood flow under low-oxygen and high-carbon-dioxide conditions. The goal is to understand basic biology that could inform future treatments for cerebrovascular disorders.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Indomethacin, Orilissa, testosterone gel, anastrozole, and estradiol
- What this could lead to
- If the trial shows that sex hormones shape brain blood flow control, it could point toward tailored treatments for stroke and other blood vessel conditions in the brain.
- What could go wrong
- The trial is small, with 22 healthy young adults, so its results may not apply to older people or those with disease. The hormone suppression and add-back can cause temporary side effects like hot flashes or mood changes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
22 people
The number who actually took part.
- Started
-
Jul 2024
- Finished
-
May 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 40 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age between ≥18 - ≤40 years inclusive * Completed Phase 1: Study 2020-0336 Exclusion Criteria: * Hypertensive * \> 125 mmHg systolic blood pressure; or * \> 80 mmHg diastolic blood pressure * BMI ≥25 kg/m2 * Fasting blood glucose ≥100 mg/dl * LDL cholesterol ≥130 mg/dl * Triglycerides ≥150 mg/dl * Current diagnosis or history of: * peripheral vascular disease * hepatic disease * renal disease * lung disease * gastrointestinal disorders/bleeding * hematologic disease * stroke * myocardial infarction * coronary heart disease * congestive heart failure * heart surgery * prediabetes * diabetes mellitus (type 1, type 2, MODY, or others) * sleep apnea * hypertension * some autoimmune diseases, such as inflammatory bowel disease or systemic lupus erythematosus (exclusion at discretion of reviewing MD) * Current smoking, defined as the use of tobacco or nicotine products \>5 times in the past 30 days. * Cardiovascular medication use * NSAID sensitivity * Magnesium-restricted diet * Any contraindications of having an MRI * (e.g. the requirement of anxiolytics in order to complete an MRI scan) * Irregular menstrual cycle (females only) * Medical conditions that can affect the menstrual cycle, such as hyperprolactinemia, prolactinoma, hypercortisolemia, and congenital adrenal hyperplasia (females only) * Pregnancy, breast feeding, or plans to conceive within the next 3 months (females only) * Polycystic ovary syndrome (females only) * Hirsutism defined as unwanted and/or excessive hair growth on the face, chest, or back (females only) * Levonorgestrel intrauterine device (IUD) (females only) * Hormonal birth control will not be allowed in women, in order to control for high variability between type, dose, and route of therapy. However, in discussion with Dr. Davis (Co-I) and Dr. Laura Cooney M.D., physician experts in medical and reproductive endocrinology and infertility, there are two broad exceptions to this birth control criteria: * Copper intrauterine devices (IUDs) will be allowed as they do not change systemic sex hormone levels). * Women currently taking hormonal birth control (i.e. contraceptive pills, patch, ring) for contraception only (not for a medical condition such as those listed in exclusion criteria above) may consider temporarily stopping to become eligible for enrollment. Hormonal birth control must be stopped at least one month prior to Study Visit 1 to provide time for menstruation to resume. Then stoppage continues through the last planned study visit. Screening information will be reviewed by endocrinology physicians to determine eligibility and timing on this issue.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Wisconsin
Madison, Wisconsin, 53705, United States
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Other studies related to the condition(s) this trial covers.
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