hCG Treatment for Rehabilitation From a TBI

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