Sex hormones may hold the key to brain blood flow control

NCT ID NCT06253702

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

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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