Hypogonadism
Conditions
Keywords
hypogonadism, testosterone, aging, Total testosterone < 300 ng/dL, Bioavailable testosterone < 70 ng/dL
Brief summary
This is a randomized controlled trial of testosterone replacement therapy in hypogonadal men age \> 60 years. The goal is to assess the safety and efficacy of TRT in men age \> 60 years.
Interventions
DRUGTestosterone
Sponsors
Solvay Pharmaceuticals
North Florida Foundation for Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
60 Years to 80 Years
Inclusion criteria
age 60-80 yrs serum total testosterone \< 300 ng/dL serum bioavailable testosterone \< 70 ng/dL
Exclusion criteria
unable to provide informed consent history of prostate or breast cancer untreated sleep apnea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical function | — |
| Cognitive function | — |
Countries
United States
Outcome results
None listed