Table 2.
Randomized control trials to investigate the effects of testosterone replacement therapy (TRT) on muscle (published since 2010).
| Author | Year | Subjects | Number | TRT Regimens (Add-on Therapy) |
Effects | Ref. | |
|---|---|---|---|---|---|---|---|
| Kolind (Denmark) |
2022 | Hypogonadal men with opioid-treated chronic pain (TT < 12 nmol/L) |
41 | TRT 20 placebo 21 |
TU 1000 mg, intramuscular for 24 weeks |
TRT did not improve muscle function (leg-press maximal voluntary contraction, leg extension power and handgrip strength). | [65] |
| Barnouin (USA) |
2021 | Hypogonadal men with obesity (TT < 10.4 nmol/L) |
83 | TRT 42 placebo 41 |
T gel daily for 6 months (diet + exercise) |
TRT might attenuate the weight loss–induced reduction in muscle mass. There was no significant difference in muscle strength between the two groups. | [66] |
| Chasland (Australia) |
2021 | Men with obesity and low-normal serum TT (TT 6–14 nmol/L) |
80 | TRT 40 placebo 40 |
T gel 100 mg/day for 23 weeks (exercise) |
TRT increased total, leg, and arm lean mass but did not affect aerobic capacity (Vo2peak) and muscle strength. | [67] |
| Glintborg (Denmark) |
2020 | Men with opioid-induced hypogonadism (TT < 12 nmol/L) |
41 | TRT 20 placebo 21 |
TU 1000 mg, intramuscular for 24 weeks |
TRT increased lean body mass. | [68] |
| Gagliano-Juca (USA) |
2018 | Older men with mobility limitations (TT < 350 ng/dL or FT < 50 pg/mL) | 99 | TRT 46 placebo 53 |
T gel 100 mg/day for 6 months |
TRT improved muscle strength and physical function (assessed by loaded stair-climbing power). | [69] |
| Storer (USA) |
2017 | Eugonadal and hypogonadal men (TT 100–400 ng/dL or FT < 50 pg/mL) |
256 | TRT 135 placebo 121 |
T gel 75 mg/day for 3 years |
TRT strengthened chest-press strength and power, and leg-press power. | [70] |
| Ng Tang Fui (Australia) |
2016 | Hypogonadal men with obesity (TT < 12 nmol/L) |
100 | TRT 49 placebo 51 |
TU 1000 mg intramuscular for 56 weeks (diet) |
TRT did not increase muscle volume but did attenuate the reduction in lean mass by diet compared with the controls. | [71] |
| Dias (USA) |
2016 | Hypogonadal men (TT < 350 ng/dL) |
39 | TRT 13 placebo 9 other 13 |
T gel 50 mg/day for 12 months |
TRT improved knee strength and fast gait at 12 months compared with baseline. | [72] |
| Konaka (Japan) |
2016 | Hypogonadal men (FT < 10.8 pg/mL) |
334 | TRT 169 control 165 |
TE 250 mg/4 weeks for 52 weeks |
TRT improved muscle volume and grip power. | [73] |
| Magnussen (Denmark) |
2016 | Hypogonadal men with DM (BioT < 7.3 nmol/L) |
43 | TRT 22 placebo 21 |
T gel 50 mg/day for 24 weeks |
TRT increased lean body mass. | [74] |
| Sinclair (Australia) |
2016 | Hypogonadal men with cirrhosis (TT < 12 nmol/L or FT < 230 pmol/L) |
101 | TRT 50 placebo 51 |
TU 1000 mg/6–12 weeks intramuscular for 12 months |
TRT increased total lean body and appendicular lean muscle mass. | [75] |
| Borst (USA) |
2014 | Hypogonadal men (TT ≤ 300 ng/dL) |
60 | TRT 31 placebo 29 |
TE 125 mg/weeks I intramuscular for 12 months (finasteride) |
TRT increased upper and lower body muscle strength by 8–14% and fat-free mass by 4.04 kg. | [76] |
| Giamatti (Australia) |
2014 | Hypogonadal men with type 2 diabetes mellitus (TT ≤ 300 ng/dL or BioT ≤ 70 ng/dL) |
88 | TRT 45 placebo 43 |
TU 1000 mg/6–12 weeks intramuscular for 56 weeks |
TRT increased lean body mass. | [77] |
| Stout (UK) |
2012 | Men with chronic heart failure (TT < 15 nmol/L) |
28 | TRT 15 placebo 13 |
Testosterone 100 mg/2 weeks intramuscular for 12 weeks (exercise) |
TRT could not improve the shuttle walk test and hand grip strength compared with placebo. | [78] |
| Behre (Australia) |
2012 | LOH men (TT < 15 nmol/L or BioT < 6.68 nmol/L) | 362 | TRT 183 placebo 179 |
T gel 50–75 mg/day for 6 months |
TRT increased lean body mass. | [79] |
| Travison (USA) |
2011 | Hypogonadal men with mobility limitation (TT 100–350 ng/dL or FT < 50 pg/mL) | 209 | TRT 106 placebo 103 |
T gel 100 mg/day for 6 months |
TRT increased leg-press and chest-press strength and stair-climbing power but could not improve walking speed. | [80] |
| Atkinson (UK) |
2010 | Hypogonadal frail men (TT < 12 nmol/L) | 30 | TRT 16 placebo 14 |
T gel 50 mg/day For 6 months. |
TRT helped preserve muscle thickness. There was no significant effect of treatment on fascicle length or pennation angle. | [81] |
| Kenny (USA) |
2010 | Hypogonadal frail men (TT < 350 ng/dL) | 131 | TRT 69 placebo 62 |
T gel 5 mg/day for 12–24 months |
There was an increase in lean mass in the testosterone group but no differences in strength or physical performance. | [50] |
| Srinivas-Shankar (UK) |
2010 | Hypogonadal frail men (TT < 12 nmol/L or FT < 250 pmol/L) | 274 | TRT 138 placebo 136 |
T gel 50 mg/day for 6 months |
Isometric knee extension peak torque was improved, and lean mass was increased in the TRT group. | [82] |
TRT, testosterone replacement therapy; TT, total testosterone; FT, free testosterone; BioT, bioavailable testosterone; TU, testosterone undecanoate; TE, testosterone enanthate.