Clinical trial: Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury (NCT04460872)

Eligibility criteria:
Inclusion Criteria:

          -  Men >18 years of age

          -  Diagnosis of an incomplete SCI involving spinal segments T12 or above, for >12-months

          -  Low serum total testosterone (<300 ng/dL), bioavailable testosterone (<75 ng/dL), or
             free testosterone (<64 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 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

          -  Locomotor dysfunction

          -  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

        Exclusion Criteria:

          -  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, syringomyelia) that may complicate study procedures

          -  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 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)

          -  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, anti-estrogen or estrogen treatment, or
             growth hormone

          -  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 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

          -  Known allergy to any component of the TRT formulation (e.g., sesame 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 (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
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Contradiction