Table 1.
Baseline Characteristics of Men Enrolled in the TTrials
| Characteristics | Treatment Group | |
|---|---|---|
| Placebo | Testosterone | |
| N | 395 | 395 |
| Demographics | ||
| Age, y | 72.3 ± 5.8 | 72.1 ± 5.7 |
| Race | ||
| Caucasian | 351 (88.9%) | 349 (88.4%) |
| African American | 20 (5.1%) | 21 (5.3%) |
| Other, % | 24 (6.1%) | 25 (6.3%) |
| Ethnicity | ||
| Hispanic, % | 10 (2.5%) | 18 (4.6%) |
| Non-Hispanic, % | 385 (97.5%) | 376 (95.2%) |
| College graduate, % | 198 (50.1%) | 214 (54.2%) |
| Concomitant conditions | ||
| BMI, kg/m2 | 31.0 ± 3.6 | 31.0 ± 3.5 |
| BMI > 30, % | 246 (62.3%) | 251 (63.5%) |
| Medication Use | ||
| 5-alpha reductase inhibitors, % | 18 (4.6%) | 15 (3.8%) |
| Sex Hormones | ||
| Testosterone, ng/dL | 236 ± 67 | 232 ± 63 |
| Free testosterone, pg/mL | 65.0 ± 23.4 | 62.0 ± 21.4 |
| Sex hormone binding globulin, nM | 29.5 ± 14.7 | 31.4 ± 15.2 |
| PSA | ||
| PSA, ng/dL, adjusteda,b | 1.55 ± 0.84 | 1.45 ± 0.86 |
| PSA, ng/dLa | 1.25 ± 0.86 | 1.14 ± 0.86 |
| Prostate cancer risk (12) | ||
| Risk, % of all prostate cancerc | 17.6 ± 6.0 | 17.3 ± 6.0 |
| Risk, % of high-grade prostate cancerc | 3.0 ± 1.7 | 2.9 ± 1.7 |
| Lower urinary tract symptoms | ||
| International Prostate Symptom Score | 9.6 ± 5.3 | 9.0 ± 5.2 |
a
PSA values were doubled for men taking a 5-alpha reductase inhibitor.
b
PSA values were adjusted for low testosterone levels. Adjusted PSA = PSA + (460 − testosterone level) × 0.00128.
c
Risk was determined by the Prostate Risk Calculator (20).