[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-cord-trauma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-cord-trauma":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":42,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100650026","phase-2-testosterone-therapy-with-or-without-finasteride-after-spinal-cord-injury-trt-sci-trial-100650026",false,"NCT07742553","Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial","A Multisite, Double-blind, Randomized Controlled Trial Comparing Body Composition, Muscle, and Bone Changes to TestosteRone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial","TRT-SCI","Inclusion Criteria:\n\n* Veterans eligible for care within the Veterans Health Administration (VHA)\n* Diagnosis of motor incomplete SCI (AIS C-D) for \\>24-months involving spinal segment lumbar (L)1 or above from trauma, vascular, or orthopedic pathology\n* Low total testosterone (\\\u003C300 nanograms\u002Fdecilliter \\[ng\u002FdL\\]) and\u002For low free testosterone (\\\u003C4.6 ng\u002FdL)\n* Presence of one or more sign of low testosterone, defined as:\n\n  * decreased energy\n  * motivation\n  * initiative or self-confidence\n  * increased fatigue or tiredness\n  * reduced sexual desire or activity\n  * decreased spontaneous (e.g., morning) erections or erectile dysfunction\n  * loss of body hair or reduced shaving\n  * feeling sad or blue or having a depressed mood or a persistent low-grade depressive disorder (defined as a score of \\>3 on the Patient Health Questionnaire \\[PHQ\\]-2)\n  * hot flashes\n  * fatigue or irritability\n  * poor concentration or memory\n  * mild unexplained (normocytic-normochromic) anemia, defined as hematocrit (HCT) \\\u003C40%, hemoglobin \\\u003C13.6 grams\u002Fdeciliter (g\u002FdL), or red blood cell count \\\u003C4.5 million\u002Fmicroliter (mcL)\n  * sleep disturbances or increased sleepiness\n  * reduced muscle bulk, strength, or physical function\n  * increased body fat or body mass index\n* Presence of motor impairment, defined as self-selected walking pace ≤1.0 meters\u002Fsecond (m\u002Fs) on a 10-meter walk test (10mWT), with or without gait devices or braces and with or without assistance from another person, or as self-selected walking pace \\>1.0 m\u002Fs with reliance on a gait device or brace or with highly compensated movement impairment identified by a trained observer\n* Medically stable condition asymptomatic for bladder infection, major decubiti, cardiopulmonary disease, or other significant condition that will interfere with the study\n* Documented approval from a physician verifying medical status\n\nExclusion Criteria:\n\n* Involvement in another research study that may influence outcomes\n* Mental state that precludes understanding the protocol\n* Life expectancy \\\u003C12 months\n* History of or current congenital spinal cord injury (SCI) (e.g., Chiari malformation, myelomeningocele, intraspinal neoplasm, Friedreich's ataxia) or degenerative spinal disorder (e.g., spinocerebellar degeneration) that may complicate procedures\n* Amyotrophic lateral sclerosis, multiple sclerosis, or other neurologic injury \u002F impairment that may complicate procedures\n* Current cancer diagnosis\n* History of prostate or breast cancer\n* Any diagnosed or treated cancer in the past 24 months, except basal or squamous cell carcinoma of the skin that has been successfully treated\n* Any major lower-limb fracture in the past 12 months\n* Unevaluated circulating prostate-specific antigen (PSA) \\>4.0 nanograms\u002Fmilliliter (ng\u002FmL) or \\>3.0 ng\u002FmL in men with prostate cancer risk factors, including agent orange exposure, first degree relative with prostate cancer, or African American background\n* Currently seeking fertility or expected during the study\n* Diagnosed gynecomastia\n* Hematocrit (HCT) \\>48%\n* Any major cardiovascular event in the last 6 months, defined as:\n\n  * an acute myocardial infarction\n  * any cardiac revascularization procedure including stenting\n  * angioplasty or coronary artery bypass grafting\n  * revascularization of the carotid or middle cerebral artery or procedure to treat critical limb ischemia\n  * hospitalization due to unstable angina\n  * transient ischemic attack\n  * stroke\n  * peripheral vascular disease\n* Any angina that is not controlled on a current medical regimen (Canadian class II, III, or IV)\n* Poorly compensated congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV)\n* Poorly controlled hypertension when on medication (consistent systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg)\n* Poorly controlled arrhythmia of any type\n* Severe valvular heart disease\n* Baseline electrocardiogram findings such as left bundle branch block or marked abnormality that precludes serial screening for occult ischemic events\n* History of unprovoked deep venous thrombosis, unprovoked pulmonary embolism, history of recurrent deep venous thrombosis or known thrombophilia\n* Major non-cardiovascular surgery (e.g., major abdominal or thoracic procedure) within 90 days before screening or a major surgery scheduled at the time of screening\n* Liver enzymes (aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\]) \\>1.5 times the normal upper limit\n* Severe or end-stage chronic kidney disease defined as eGFR \\\u003C30 milliliters\u002Fminute (mL\u002Fmin)\n* Diagnosed, but untreated severe obstructive sleep apnea\n* Use of an agent that alters sex-steroid metabolism in the past 90 days, such as: testosterone therapy (TRT), compounded or over-the-counter androgenic hormone or androgen precursor, 5-alpha reductase (5AR) inhibitors, growth hormone, clomiphene, aromatase inhibitors, anti-estrogen or estrogen treatment, or others\n* Use of anti-resorptive or bone anabolic drug therapy in the past 180 days\n* Acute use (\\>5 days) of any opioid (e.g., oxycodone, hydrocodone) or systemic glucocorticoids \\>7.5 milligrams (mg)\u002Fday prednisone equivalent (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) in the week before screening, except for men who are taking these for a chronic condition and who are anticipated to continue these for the study duration\n* Known allergy to any TRT component (e.g., cottonseed oil or other)\n* Any other condition, lab abnormality, therapy, medical or psychiatric condition, or reason that might pose a risk to the participant, make participation not in the person's best interest, confound the study results (e.g., inability to comply with study requirements), make the participant unsuitable to receive a study intervention, or interfere with their ability to participate for the full study duration","MALE","18 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Spinal cord injury (SCI) results in lower limb muscle loss, bone loss, and high fat mass that impede the recovery of physical function, increase bone fracture risk, and worsen health and quality of life. These deficits result from reduced activity after SCI and may be worsened by low testosterone, which is present in many men with SCI. In older men with low testosterone who do not have SCI, testosterone therapy (TRT) is known to increase muscle mass, muscle strength, and bone mineral density, and to reduce body fat. However, it is not known if TRT is effective in men with SCI. The purposes of this study are to determine the effectiveness of TRT in men who have low testosterone and difficulty walking after chronic motor incomplete SCI and to assess whether a process in the body that changes testosterone to dihydrotestosterone (DHT; another hormone that is stronger than testosterone) impacts the effectiveness of TRT in the impaired lower limbs and in other tissues after SCI. The researchers hypothesize that TRT will improve muscle and bone in the impaired limbs of men with chronic incomplete SCI and reduce fat mass, and that finasteride (a drug that blocks that blocks a process that changes testosterone to DHT) will influence prostate symptoms but not the musculoskeletal or body composition benefits produced by TRT.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Spinal Cord Injury","Spinal Cord Injuries","Injuries, Spinal Cord","Spinal Cord Contusion","Spinal Cord Trauma","Trauma, Nervous System","Wounds and Injuries","Spinal Cord Compression","Nervous System Diseases","Spinal Cord Diseases","Gonadal Disorders","Endocrine System Diseases","Hypogonadism","Genital Diseases, Male",[43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,28,82,83,84,85,86,29,33,34,87,36,37,38,39,40,41,88],"Testosterone","Testosterone cypionate","Testosterone enanthate","Testosterone 17 beta-cypionate","Testosterone undecanoate","Methyltestosterone","Testosterone propionate","Dihydrotestosterone","Androgens","Hormones","Hormone Substitutes, and Hormone Antagonists","Physiologic Effects of Drugs","Pharmacologic Actions","Therapeutic Uses","Anabolic Agents","Testosterone Therapy","Testosterone Replacement Therapy","Dual Energy X ray Absorptiometry","Lean Tissue Mass","Body Composition","Lipid and Glucose profile","Muscle Strength","5-alpha Reductase","Muscle Mass","Bone Mineral Density","Adipose Tissue","Fat Mass","Body Fat","Density, Bone","Bone Formation","Bone Resorption","Bone Density Conservation Agents","Muscle, Skeletal","Bone and Bones","Gait","Walking","Locomotion","Motor Activity","Finasteride","Genital Diseases","Urogenital Diseases","Male Urogenital Diseases","Bone Diseases","Musculoskeletal Diseases","Central Nervous System Diseases","Steroids","NOT_YET_RECRUITING","2026-08-03",{"date":92,"type":93},"2026-08-04","ACTUAL",{"date":95,"type":21},"2027-10-01",{"date":97,"type":21},"2032-03-31",{"name":99,"class":100},"VA Office of Research and Development","FED",4,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":121,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":5},"100397880","phase-2-locomotor-training-with-testosterone-to-promote-bone-and-muscle-health-after-spinal-cord-injury-100397880","NCT04460872","Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury","Locomotor Training With Testosterone to Promote Bone and Muscle Health","Inclusion Criteria:\n\n* Men \\>18 years of age\n* Diagnosis of an incomplete SCI involving spinal segments L1 or above or a clinically complete SCI involving spinal segments T2-L1, with upper motor neuron injury signs (i.e., spasticity, hypertonicity) for \\>60-days\n* Low serum total testosterone (\\\u003C300 ng\u002FdL), bioavailable testosterone (\\\u003C110 ng\u002FdL), or free testosterone (\\\u003C46 pg\u002FmL or \\\u003C4.6 ng\u002FdL)\n* Presence of one or more sign or symptom that may be related to low testosterone, including: loss of body hair or reduced shaving, very small testes (\\\u003C6 mL), reduced sexual desire (libido) and activity, decreased spontaneous erections (e.g., morning erections) or erectile dysfunction, breast discomfort or gynecomastia, height loss, low-trauma fracture, or low BMD, hot flushes or sweats, decreased energy, motivation, initiative, or self-confidence, fatigue or irritability, feeling sad or blue, having a depressed mood, or having a persistent low-grade depressive disorder, poor concentration or memory, sleep disturbances or increased sleepiness, mild unexplained anemia (normochromic or normocytic), reduced muscle bulk, strength, or physical performance, Increased body fat or body mass index, any other sign or symptom commonly associated with low testosterone\n* Locomotor dysfunction, definted as self-selected walking pace ≤1.0 m\u002Fs on a 10mWT, either with or without gait devices or braces and with or without assistance, or as self-selected walking pace \\>1.0 m\u002Fs with reliance on a gait device or brace or with highly compensated movement impairments, as identified by a trained observer.\n* Diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology\n* Medically-stable condition that is asymptomatic for conditions that will interfere with the study participation\n* Willingness to administer TRT as instructed by the study staff and to abide by study protocol\n* Documented approval from the study physician verifying medical status\n\nExclusion Criteria:\n\n* Currently participating in another research protocol that may influence study outcomes.\n* Mental state that precludes understanding the study protocol.\n* Life expectancy \\\u003C12-months.\n* History of or current congenital SCI (e.g., Chiari malformation, myelomeningocele, intraspinal neoplasm, Frederich's ataxis) or other degenerative spinal disorder (e.g., spinocerebellar degeneration) that may complicate study procedures\n* Multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment or injury\n* Current prostate, breast, or other organ cancer or a history of prostate or breast cancer\n* Any other diagnosed or treated cancer within the past 24-months, with the exceptions of basal or squamous cell carcinoma of the skin that has been successfully treated\n* Serum prostate-specific antigen (PSA) \\>3.0 ng\u002FmL \\[men treated with 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are eligible to participate if PSA values are ≤1.5 ng\u002FmL\\]\n* Prostate nodule or induration noted on digital rectal exam (DRE) during screening that tests positive for prostate cancer\n* Currently seeking fertility or expected during the duration of the study\n* Gynecomastia\n* Hematocrit (HCT) \\>49%\n* Any major cardiovascular (CV) event within the last 12-months (defined as a history of acute myocardial infarction, any cardiac revascularization procedure including angioplasty, stenting, or coronary artery bypass grafting, revascularization of the carotid or middle cerebral artery or procedures to treat critical limb ischemia, or hospitalization due to unstable angina, transient ischemic attack, stroke, or peripheral vascular disease)\n* Angina that is not controlled on a current medical regimen (Canadian class II, III, or IV)\n* Poorly compensated congestive heart failure (NYHA class III or IV)\n* Poorly controlled hypertension (consistently measured systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg), while on medications\n* Poorly controlled arrhythmia of any type\n* Severe valvular heart disease\n* Baseline electrocardiogram (ECG) findings such as left bundle branch block or marked ECG abnormalities that would preclude serial screening evaluations for occult ischemic events\n* History of unprovoked deep venous thrombosis (DVT), unprovoked pulmonary embolism, history of recurrent DVT or known thrombophilia\n* LDL cholesterol \\>160 mg\u002FdL with history of any major CV event, defined above, within the last 12-months\n* Major non-CV surgery (e.g., major abdominal or thoracic procedure) within 90-days prior to screening and\u002For a major surgery scheduled at the time of screening\n* Liver enzymes (AST or ALT) \\>1.5 times the normal upper limit\n* Severe or end-stage chronic kidney disease documented by estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n* Diagnosed, but untreated severe obstructive sleep apnea\n* Lower extremity fracture in the last 12-months (exclusion criterion for participation in LT+TRT group only)\n* Femoral neck, total hip, or lumbar spine t-score below -2.5 or distal femur BMD \\\u003C0.70 g\u002Fcm2, assessed via DEXA at screening (exclusion criterion for participation in LT+TRT group only)\n* Current anticoagulant therapy (contraindication for i.m. injections)\n* Use of any of the following pharmacologic agents in the previous 90-days: any TRT formulation, any compounded or over-the-counter androgenic hormones or androgen precursors, clomiphene, aromatase inhibitors, anti-estrogen or estrogen treatment, or growth hormone\n* Use of anti-resorptive or bone anabolic drug therapy in the previous 180-days\n* Acute use (\\>5-days) of any opioids (e.g., oxycodone, hydrocodone, etc) or systemic glucocorticoids \\>7.5 mg\u002Fd prednisone equivalent (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) within 1-week before screening visit, except men who are taking these medications for a chronic condition and are anticipated to continue treatment for the study duration\n* Known allergy to any component of the TRT formulation (e.g., sesame oil or cottonseed oil)\n* Any other condition, therapy, lab abnormality, medical or psychiatric conditions, or reason that might pose a risk to the participant, make participation not in the person's best interest, confound the study results (e.g., inability to comply with study requirements), make the participant unsuitable to receive study intervention, or interfere with the person's ability to participate for the entire study duration",{"count":110,"type":21},21,[24],"This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.",[28,29,33,114,87,37,38,39,40,41,32,30,115,116,117,34,36,118,119,120],"Wounds and Injury","Walking, Difficulty","Gait Disorders, Neurologic","Locomotion Disorder, Neurologic","Testosterone Deficiency","Androgen Deficiency","Hormone Deficiency",[43,45,47,46,48,51,52,53,54,55,56,57,59,60,61,62,64,66,67,68,70,71,72,73,74,122,78,123,124,79,125,28],"Magnetic Resonance Imaging","Ambulation","Locomotor","Treadmill","RECRUITING","2025-05-01",{"date":129,"type":93},"2025-05-06",{"date":131,"type":93},"2021-01-31",{"date":133,"type":21},"2026-06-30",{"name":135,"class":136},"North Florida Foundation for Research and Education","OTHER"]