Table 2.
Physical Function Trial Outcomes.*
| Cohort and Outcome | No. of Men | Baseline Value | No. of Participants or Change from Baseline Value | Treatment Effect (95% CI)† | Effect Size (95% CI)‡ | P Value§ | |||
|---|---|---|---|---|---|---|---|---|---|
| Month 3 | Month 6 | Month 9 | Month 12 | ||||||
| Men enrolled in Physical Function Trial | |||||||||
| Primary outcome: increase of ≥ 50 m in 6-min walk test — no./total no. (%) | |||||||||
| Testosterone | 191 | 20/179 (11.2) | 24/174 (13.8) | 28/172 (16.3) | 35/172 (20.3) | 1.42 (0.83 to 2.45) | 0.20 | ||
| Placebo | 196 | 14/179 (7.8) | 23/171 (13.5) | 22/159 (13.8) | 20/165 (12.1) | ||||
| Secondary outcomes | |||||||||
| 6-Min walking distance — m | |||||||||
| Testosterone | 191 | 347.7±69.1 | 10.2±35.8 | 8.2±41.5 | 5.3±50.3 | 14.3±45.9 | 4.09 (−3.00 to 11.18) | 0.06 (−0.04 to 0.16) | 0.28 |
| Placebo | 196 | 344.9±68.5 | 4.6±35.2 | 7.8±41.4 | 3.2±52.4 | 5.5±46.4 | |||
| Increase of ≥8 in PF-10 score — no./total no. (%)¶ | |||||||||
| Testosterone | 184 | 77/176 (43.8) | 72/171 (42.1) | 77/172 (44.8) | 66/173 (38.2) | 1.34 (0.90 to 2.00) | 0.15 | ||
| Placebo | 181 | 59/171 (34.5) | 73/159 (45.9) | 60/159 (37.7) | 58/167 (34.7) | ||||
| PF-10 score¶ | |||||||||
| Testosterone | 184 | 65.4±20.0 | 5.6±15.2 | 6.5±16.7 | 5.9±19.4 | 5.8±17.5 | 2.75 (0.20 to 5.29) | 0.13 (0.01 to 0.26) | 0.03 |
| Placebo | 181 | 64.8±21.3 | 4.2±13.7 | 4.8±17.0 | 3.3±18.9 | 2.4±17.3 | |||
| All Testosterone Trials participants|| | |||||||||
| Increase of ≥ 50 m in 6-min walk test — no./total no. (%) | |||||||||
| Testosterone | 392 | 40/368 (10.9) | 52/358 (14.5) | 54/348 (15.5) | 71/346 (20.5) | 1.76 (1.21 to 2.57) | 0.003 | ||
| Placebo | 389 | 25/356 (7.0) | 39/339 (11.5) | 37/320 (11.6) | 41/326 (12.6) | ||||
| 6-Min walking distance — m | |||||||||
| Testosterone | 392 | 387.0±81.7 | 10.9±45.1 | 11.0±40.2 | 6.7±45.1 | 13.6±43.4 | 6.69 (1.80 to 11.57) | 0.08 (0.02 to 0.14) | 0.007 |
| Placebo | 389 | 387.0±83.7 | 1.6±41.9 | 5.7±45.1 | 3.2±47.4 | 6.4±45.8 | |||
| Increase of ≥ 8 in PF-10 score — no./total no. (%)¶ | |||||||||
| Testosterone | 309 | 111/285 (38.9) | 113/281 (40.2) | 115/276 (41.7) | 103/281 (36.7) | 1.50 (1.08 to 2.09) | 0.02 | ||
| Placebo | 305 | 87/275 (31.6) | 103/263 (39.2) | 89/260 (34.2) | 82/272 (30.1) | ||||
| PF-10 score¶ | |||||||||
| Testosterone | 309 | 71.2±20.2 | 5.0±14.7 | 6.1±16.7 | 5.3±18.5 | 4.3±16.9 | 3.06 (1.18 to 4.94) | 0.15 (0.06 to 0.24) | 0.002 |
| Placebo | 305 | 69.7±21.2 | 3.9±12.8 | 3.4±16.2 | 2.3±17.9 | 1.3±16.9 | |||
Plus–minus values are means ±SD.
The treatment effect for dichotomous outcomes is the odds ratio for achieving the outcome versus not achieving the outcome among men assigned to testosterone versus those assigned to placebo. For continuous outcomes, the treatment effect is the mean difference in the outcome among men assigned to testosterone versus those assigned to placebo. All analyses are adjusted for balancing factors: baseline total testosterone level (≤200 or >200 ng per deciliter), age (≤75 or >75 years), trial site, participation in the main trials, use or non-use of antidepressants, and use or nonuse of phosphodiesterase type 5 inhibitors.
For continuous outcomes, the effect size is the treatment effect divided by the baseline standard deviation.
The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.
Scores on the physical-function scale (PF-10) of the Medical Outcomes Study 36-Item Short-Form Health Survey range from 0 to 100, with higher scores indicating better function.
The outcomes for all Testosterone Trials participants are exploratory outcomes.