Table 1.
Studies of testosterone therapy (duration 6 months or less) in healthy older men
| First author, year (Ref.) | Study protocol, active treatment, duration, no. of subjects | Main subject characteristics | Main findings and remarks |
|---|---|---|---|
| Ferrando, 2002 (443) | Parallel groups | Healthy older men | High supraphysiological doses of T |
| T enanthate im, weekly in the first month, then every 2 wk | Age, >60 yr | Increase in total and appendicular LBM, decrease in BF, increase in muscle strength | |
| Variable doses (50–400 mg) to maintain nadir T >490 ng/dl | T, <480 ng/dl (17 nmol/liter) | Improvement in skeletal muscle protein turnover | |
| Duration, 6 months | Baseline T, 279–458 ng/dl | No changes in PSA levels | |
| Act, n = 7; PL, n = 5 | |||
| Münzer, 2001 (576); Blackman, 2002 (49); Christmas, 2002 (583); Huang, 2005 (598); Münzer, 2009 (645) | Parallel groups | Community-dwelling healthy older men | Subcutaneous fat decreased; no changes recorded in any of the outcome measurements reported |
| T enanthate im, 100 mg/2 wk | Age, 65–88 yr | ||
| Duration, 6 months | T, <470 ng/dl | ||
| Act, n = 15–21; PL, n = 17 | Baseline T, 440 ± 23 ng/dl | ||
| Giannoulis, 2006 (48, 646); and 2008 (597) | Parallel groups | Community-dwelling healthy older men | No changes in body composition, muscle function, lipid profile, or WBPK |
| T patch, 5 mg/d fixed dose | Age, 65–85 yr | ||
| Duration, 6 months | |||
| Act, n = 23; PL, n = 20 (dropouts, Act, n = 2; PL, n = 4) | Baseline T, 496 ± 63 ng/dl | ||
| Katznelson, 2006 (606) | Parallel groups | Community-dwelling healthy older men | Improvements in QoL after combined Ex and T |
| T patch (5 mg/d) ± Ex | Age, 65–85 yr | ||
| Duration, 12 wk | FT, ≤14.5 pg/ml | ||
| Act T, n = 17; Act T+Ex, n = 17; PL+Ex, n = 19 (dropouts, Act, n = 3; PL, n = 4) | Baseline T, 391 ng/dl (25–512 ng/dl) | ||
| Tenover, 1992 (586) | Crossover | Community-dwelling, healthy older men | |
| T enanthate, 100 mg/wk im | Age, 57–76 yr | Increase in LBM and decrease in markers of bone resorption | |
| Duration, 3 months | T, <400 ng/dl | Increase in PSA and hematocrit levels | |
| n = 13 | Baseline T, 334 ± 14 ng/dl | ||
| Emmelot-Vonk, 2008 (584) | Parallel groups | Community-dwelling healthy older men | Improvements in body composition, but no changes in muscle strength, physical function, BMD, QoL |
| T undecanoate, 80 mg twice daily orally | Age, 60–80 yr | Adverse effect on the lipid profile | |
| Duration, 6 months | T, ≤395 ng/dl (13.7 nmol/liter) | No changes in PSA | |
| Act, n = 120; PL, n = 117 (dropouts, Act, n = 16, PL, n = 14) | Baseline T, 317 ng/dl | ||
| Clague, 1999 (637) | Parallel groups | Community-dwelling healthy older men | Total body mass, hemoglobin, and packed cell volume increased; no effects on strength |
| T enanthate, 200 mg/2 wk im | Age, >60 yr | ||
| Duration, 12 wk | T, <403 ng/dl | ||
| Act, n = 70; PL, n = 7 | Baseline T, 325 ± 49 ng/dl |
All studies are randomized, placebo-controlled, and double blind. Seven trials were identified where T was administered in accepted forms for replacement treatment in healthy subjects and not in older men (aged >60 yr) who were frail or had other associated comorbidities that have reported on outcome measurements related to physical function. Of the 444 subjects included, 219 received T. Act, Active treatment; PL, placebo; Ex, exercise.