Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Pregnancy hormone may reboot brain after injury

NCT ID NCT07557615

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests whether a hormone called hCG (Ovidrel) can help men recover thinking and daily living skills after a moderate to severe traumatic brain injury. Fifty men will receive either the hormone or a placebo twice a week for 24 weeks. The main goal is to check safety, but researchers will also measure changes in independence and brain function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
human chorionic gonadotropin (hCG, Ovidrel)
What this could lead to
If it works, this could point toward a new way to boost recovery of thinking and daily function after a traumatic brain injury.
What could go wrong
This is a very early, small trial (50 men) testing safety first. It may not show clear benefit, and side effects are unknown.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Male subjects aged 18-65 * Subject is 1-month but \< 6-month post-TBI with a msTBI defined as Glasgow Coma Scale (GCS) 4-12 (inclusive) at the time of the TBI, and/or at the time of screening (Visit 1) * Stable doses of any medication, supplement or medical food that may affect brain function, unless deemed medically necessary by the patient's physician for optimal healthcare * Fluent in English * Reasonable expectation of availability to receive the 24-week course of therapy and be available for follow up evaluations Exclusion Criteria: * Significantly depressed (Geriatric Depression Scale \> 10) * Patients considered to be at risk for suicidality or homicidality according to the Columbia Suicide Severity Rating Scale (CSSRS) * Primary hypogonadism (unrelated to trauma) * Renal disease; Asthma; known endocrine or germ cell tumor * Taking other medications known to affect serum sex hormone or gonadotropin concentrations such as testosterone for hormone replacement therapy, goserelin or danazol, in the past three (3) months * Presence of significant systemic illness likely to interfere with participation in or completion of the study or to affect study results * Receiving other investigational drugs within 30 d or 5 half-lives prior to randomization, whichever longer * Male patients with known/documented elevated PSA levels, or a PSA level of 4ng/mL at screening * History of deep venous thrombosis (DVT) or venous thromboembolism (VTE) * Clinically significant peripheral edema * History of sleep apnea * Severe symptoms of benign prostatic hyperplasia (BPH), i.e., International Prostate Symptom Score greater than or equal to 20 points * Patients with known hypercoagulability, including cardiolipin/antiphospholipid antibody syndrome * Allergy or other contraindication to hCG * Uncontrolled hypertension, defined as blood pressure persistently above 140 mm Hg systolic or 95 mm Hg diastolic despite antihypertensive therapy * Uncontrolled thyroid, adrenal or pituitary dysfunction * An uncontrolled organic intracranial lesion such as a pituitary tumor * History of breast or prostate cancer; sex hormone dependent tumors of the reproductive organs or accessory sex glands * Taking hCG, or any condition known to elevate hCG, active in the prior 24 mo. e.g., choriocarcinoma or germ cell tumor * Patients who have 6 or more symptoms for substance use disorder according to DSM-5 criteria * Patients with evidence of an active or previous thrombotic event

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Traumatic brain injury are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

    Madison, Wisconsin, 53705-2254, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.