TOM: Testosterone in Older Men With Sarcopenia
Condition: Sarcopenia; Hypogonadism; Muscular Diseases
MeSH terms: Muscular Diseases; Sarcopenia; Hypogonadism
Intervention: Topical testosterone gel 1% (active formulation); Topical gel (placebo formulation)
Intervention description: Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.; Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
Intervention MeSH terms: Testosterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 209.0
Sex: Male
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Andropause; frailty; hormone replacement therapy; Aging

Summary:

      The purpose of this study is to determine whether testosterone replacement in older men with
      low testosterone levels will increase muscle strength, improve physical performance and
      overall sense of well being, and reduce fatigue.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Community dwelling, ages 65 and older

          -  Self-reported difficulty in climbing 10 steps without resting, or difficulty in
             walking 2 or 3 blocks outside on level ground

          -  A score of 4 to 9 on the Short Physical Performance Battery (mild to moderate physical
             impairment)

          -  Total serum testosterone level (TT) < 350 ng/dL and > 100 ng/dL

          -  Without dementia (Mini-Mental State Examination [MMSE] score > 24)

        Exclusion Criteria:

          -  Use of testosterone, anabolic steroids, dehydroepiandrosterone (DHEA), androstenedione
             or recombinant growth hormone (rGH) in the past year

          -  Alcohol or drug abuse

          -  Use of anti-convulsants or glucocorticoids (equivalent to prednisone > 20 mg/day)

          -  Prostate cancer, breast cancer or other cancers with life expectancy < 5 years

          -  Limiting neuromuscular, joint or bone disease, or history of stroke with residual
             neurological problems

          -  Any neurological condition that would impact cognitive functioning including:

               -  epilepsy

               -  multiple sclerosis

               -  HIV

               -  Parkinson's disease

               -  stroke

               -  other focal lesion

          -  Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I
             psychiatric disorder in past year or use of psychotropic medications in 6 months

          -  Abnormal prostate examination; PSA > 4 ng/mL; or BPH symptom score > 21

          -  Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial
             infarction within 3 months of entry

          -  Abnormal laboratory values (at discretion of principal investigator)

          -  Untreated thyroid disease; systolic blood pressure > 160 or diastolic > 100 mm Hg

          -  Body mass index > 40 kg/m2

          -  Untreated severe obstructive sleep apnea