Pregnancy hormone may reboot brain after injury
NCT ID NCT07557615
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 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: * 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.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
- Can group wellness classes improve life after brain injury or dementia?
- Can a web program rebuild memory after brain injury?
- Why a simple fall can cause brain bleeding in older adults
- Bedside ultrasound could flag hidden brain injury decline
- Zapping the brain to restore lost vision
- Machine learning may forecast brain decline after head injury