Table 1.
Baseline characteristics (safety population)
| Testosterone | Placebo | Total | |
|---|---|---|---|
| n | 108 | 112 | 220 |
| Age (years) | 59.9 ± 9.1 (37−77) | 59.9 ± 9.4 (39−88) | 59.9 ± 9.3 (37−88) |
| Race | |||
| Caucasian | 105 (97) | 110 (98) | 215 (98) |
| Asian | 3 (3) | 0 | 3 (1) |
| Afro-Caribbean | 0 | 1 (1) | 1 (0.5) |
| Other | 0 | 1 (1) | 1 (0.5) |
| Total serum testosterone (nmol/L) | 9.2 ± 2.6 (3.8−20.1) | 9.5 ± 3.3 (2.2−20.6) | 9.4 ± 3.0 (2.2−20.6) |
| Free testosterone (pmol) | 198.0 ± 49.3 (42−319) | 202.4 ± 62.1 (35−364) | 200.3 ± 56.1 (35−364) |
| Type 2 diabetes | 68 (6) | 69 (62) | 137 (62) |
| MetS | 88 (82) | 88 (79) | 176 (80) |
| Insulin resistance (HOMA-IR index) | 5.9 ± 3.8 (1−20) | 4.9 ± 3.3 (1−21) | 5.4 ± 3.6 (1−21) |
| Hematocrit (L/L) | 0.43 ± 0.04 (0.34−0.54) | 0.43 ± 0.04 (0.33−0.51) | 0.43 ± 0.04 (0.33−0.54) |
| Hemoglobin (g/dL) | 14.9 ± 1.5 (11.0−18.6) | 14.9 ± 1.3 (11.4−18.0) | 14.9 ± 1.4 (11.0−18.6) |
| PSA (μg/L) | 1.6 ± 1.8 (0.21−13.60) | 1.2 ± 1.2 (0.20−6.38) | 1.4 ± 1.5 (0.20−13.60) |
| FSH* (IU/L) | 12.3 ± 13.4 (1.2−63.6) | 12.5 ± 15.7 (1.2−78.9) | 12.4 ± 14.5 (1.2−78.9) |
| FSH* | |||
| Low | 0 | 0 | 0 |
| Normal | 77 (71) | 79 (71) | 156 (71) |
| High | 31 (29) | 33 (29) | 64 (29) |
| LH* (IU/L) | 5.7 ± 5.7 (0.9−34.3) | 5.3 ± 5.4 (0.6−36.1) | 5.5 ± 5.5 (0.6−36.1) |
| LH* | |||
| Low | 0 | 2 (2) | 2 (1) |
| Normal | 86 (80) | 92 (82) | 178 (81) |
| High | 22 (20) | 18 (16) | 40 (18) |
Data are mean ± SD (range) or n (%) unless otherwise indicated. FSH, follicle stimulating hormone; LH, luteinizing hormone.
*Screening values (not measured at baseline). Normal ranges: 0.7 IU/L ≤ FSH ≤ 11.1 IU/L; 0.8 IU/L ≤ LH ≤ 7.6 IU/L.