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New treatment option for Spinal Cord Injury
Official title Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury
ClinicalTrials.gov ID: NCT04460872
What this study is testing
What is Testosterone Enanthate?
Testosterone Enanthate is an investigational medicine, given as an once-weekly injection into a muscle, being studied as a potential treatment for spinal cord injury.
Also referred to as delatestryl.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Men \>18 years of age
- Diagnosis of an incomplete SCI involving spinal segments L1 or above or a clinically complete SCI involving spinal segments T2-L1, with upper motor...
- Low serum total testosterone (\<300 ng/dL), bioavailable testosterone (\<110 ng/dL), or free testosterone (\<46 pg/mL or \<4.6 ng/dL)
- 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...
- Locomotor dysfunction, definted as self-selected walking pace ≤1.0 m/s on a 10mWT, either with or without gait devices or braces and with or without...
You likely can't join if
- Currently participating in another research protocol that may influence study outcomes.
- Mental state that precludes understanding the study protocol.
- Life expectancy \<12-months.
- History of or current congenital SCI (e.g., Chiari malformation, myelomeningocele, intraspinal neoplasm, Frederich's ataxis) or other degenerative...
- Multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment or injury
- Current prostate, breast, or other organ cancer or a history of prostate or breast cancer
See the full eligibility criteria
- Men \>18 years of age
- 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
- Low serum total testosterone (\<300 ng/dL), bioavailable testosterone (\<110 ng/dL), or free testosterone (\<46 pg/mL or \<4.6 ng/dL)
- 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 (\<6 mL), reduced sexual desire (libido) and activity, decreased...
- Locomotor dysfunction, definted as self-selected walking pace ≤1.0 m/s 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/s with reliance...
- Diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology
- Medically-stable condition that is asymptomatic for conditions that will interfere with the study participation
- Willingness to administer TRT as instructed by the study staff and to abide by study protocol
- Documented approval from the study physician verifying medical status
- Currently participating in another research protocol that may influence study outcomes.
- Mental state that precludes understanding the study protocol.
- Life expectancy \<12-months.
- 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...
- Multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment or injury
- Current prostate, breast, or other organ cancer or a history of prostate or breast cancer
- 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
- Serum prostate-specific antigen (PSA) \>3.0 ng/mL [men treated with 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are eligible to participate if PSA values are ≤1.5 ng/mL]
- Prostate nodule or induration noted on digital rectal exam (DRE) during screening that tests positive for prostate cancer
- Currently seeking fertility or expected during the duration of the study
- Gynecomastia
- Hematocrit (HCT) \>49%
- 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...
- Angina that is not controlled on a current medical regimen (Canadian class II, III, or IV)
- Poorly compensated congestive heart failure (NYHA class III or IV)
- Poorly controlled hypertension (consistently measured systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg), while on medications
- Poorly controlled arrhythmia of any type
- Severe valvular heart disease
- Baseline electrocardiogram (ECG) findings such as left bundle branch block or marked ECG abnormalities that would preclude serial screening evaluations for occult ischemic events
- History of unprovoked deep venous thrombosis (DVT), unprovoked pulmonary embolism, history of recurrent DVT or known thrombophilia
- LDL cholesterol \>160 mg/dL with history of any major CV event, defined above, within the last 12-months
- Major non-CV surgery (e.g., major abdominal or thoracic procedure) within 90-days prior to screening and/or a major surgery scheduled at the time of screening
- Liver enzymes (AST or ALT) \>1.5 times the normal upper limit
- Severe or end-stage chronic kidney disease documented by estimated glomerular filtration rate (eGFR) \<30 mL/min
- Diagnosed, but untreated severe obstructive sleep apnea
- Lower extremity fracture in the last 12-months (exclusion criterion for participation in LT+TRT group only)
- Femoral neck, total hip, or lumbar spine t-score below -2.5 or distal femur BMD \<0.70 g/cm2, assessed via DEXA at screening (exclusion criterion for participation in LT+TRT group only)
- Current anticoagulant therapy (contraindication for i.m. injections)
- 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...
- Use of anti-resorptive or bone anabolic drug therapy in the previous 180-days
- Acute use (\>5-days) of any opioids (e.g., oxycodone, hydrocodone, etc) or systemic glucocorticoids \>7.5 mg/d prednisone equivalent (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) within...
- Known allergy to any component of the TRT formulation (e.g., sesame oil or cottonseed oil)
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States; Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.