Table 4.
Summary of Results of Four Other Testosterone Trials (Cognitive Function, Anemia, Bone, and Cardiovascular)
| Testosterone Trial | Participants (n) | Mean Difference or ORa (95% CI) | Effect Sizeb | P Value | Interpretation |
|---|---|---|---|---|---|
| Cognitive Function Trial | |||||
| Verbal memory; delayed paragraph recallc | Men with age-associated memory impairment (493) | −0.07 (−0.92 to 0.79) | −0.01 (−0.14 to 0.12) | 0.88 | Testosterone treatment did not change several aspects of cognitive function in men who had age-associated memory impairment |
| Verbal memory; delayed paragraph recall | All TTrials men (785) | 0.09 (−0.57 to 0.75) | 0.01 (−0.09 to 0.11) | 0.80 | |
| Visual memory; Benton visual retention test | Men with age-associated memory impairment (492) | −0.28 (−0.76 to 0.19) | −0.09 (−0.24 to 0.06) | 0.24 | |
| Spatial ability; card rotation test | Men with age-associated memory impairment (488) | −0.12 (−1.89 to 1.65) | −0.01 (−0.13 to 0.11) | 0.89 | |
| Executive function; trail-making test B-A, sd | Men with age-associated memory impairment (490) | −5.51 (−12.91 to 1.88) | −0.09 (−0.22 to 0.03) | 0.14 | |
| Anemia Trial | |||||
| Hemoglobin increase from baseline ≥1.0 g/dL,c % | TTrials men with unexplained anemia (62) | 31.5 (3.7–277.8) | — | 0.002 | Testosterone substantially increased hemoglobin and corrected mild anemia in both men who had unexplained anemia and men who had anemia of known cause |
| Hemoglobin, g/dL | TTrials men with unexplained anemia (62) | 0.83 (0.48–1.39) | 1.30 (0.75–2.18) | <0.001 | |
| Hemoglobin increase from baseline ≥1.0 g/dL, % | TTrials men with anemia of known cause (64) | 8.2 (2.1–31.9) | — | 0.003 | |
| Hemoglobin, g/dL | TTrials men with anemia of known (64) | 0.64 (0.12–1.17) | 0.90 (0.17–1.65) | 0.018 | |
| Bone Trial | |||||
| Spine trabecular vBMD,c % change from baseline | Enrollees in Bone Trial (207) | 6.8 (4.8–8.7) | 0.23 (0.17–0.29) | <0.001 | Testosterone treatment substantially increased vBMD, more of trabecular bone than peripheral bone and more in vertebrae than in hip |
| Spine whole bone vBMD, % change from baselined | Enrollees in Bone Trial (207) | 4.2 (3.2–5.3) | 0.12 (0.09–0.15) | <0.001 | |
| Hip trabecular vBMD, % change from baseline | Enrollees in Bone Trial (191) | 1.5 (0.9–2.0) | 0.04 (0.03–0.06) | <0.001 | |
| Hip whole bone vBMD, % change from baseline | Enrollees in Bone Trial (191) | 1.3 (0.8–1.7) | 0.03 (0.02–0.04) | <0.001 | |
| Cardiovascular Trial | |||||
| Noncalcified coronary artery plaque volume,c mm3 | Enrollees in CV Trial (138) | 41 (14–67) | 0.11 (0.04–0.19) | 0.003 | Testosterone was associated with an increase in noncalcified coronary artery plaque volume but not calcified coronary artery calcium score |
| Total coronary artery plaque volume, mm3 | Enrollees in CV Trial (138) | 47 (13–80) | 0.09 (0.02–0.15) | 0.006 | |
| Coronary artery calcium score, Agatston units | Enrollees in CV Trial (138) | −27 (−80 to 26) | −0.03 (−0.07 to 0.02) | 0.31 |
Abbreviations: CI, confidence interval; CV, cardiovascular.
Treatment effect: for continuous outcomes, the treatment effect was the mean change in men allocated to testosterone minus the mean change in men allocated to placebo, adjusted for balancing factors: baseline total testosterone level (≤200 or >200 ng/dL), age (≤75 or >75 years), trial site, participation in the main trials, use or nonuse of antidepressants use or nonuse of phosphodiesterase type 5 inhibitors, and baseline value of the outcome variable; for binary outcomes, the adjusted OR was the ratio of the outcome in men allocated to testosterone to the outcome in men allocated to placebo, adjusted for the same balancing factors.
The effect size for continuous outcomes was calculated from the mean difference divided by the baseline standard deviation pooled across treatment arms; an effect size of 0.2 is considered a small effect, 0.5 a medium effect, and 0.8 a large effect.
The primary outcome of the trial.
Lower scores reflect better function.