Variable | Observed value | Change from baseline | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Intervention (VISPO) n = 33 | Comparator (SPO) n = 33 | Placebo n = 33 | p-value** | Intervention (VISPO) n = 33 | p-value* | Comparator (SPO) n = 33 | p-value* | Placebo n = 33 | p-value* | p-value** | |
Prostate specific antigen (PSA) (ng/ml) | |||||||||||
Visit 1 | 2.77 ± 0.56 | 2.80 ± 0.72 | 2.83 ± 0.52 | 0.931(1) | |||||||
Visit 3 | 2.70 ± 0.59 | 2.99 ± 0.66 | 3.01 ± 0.54 | 0.072(1) | −0.07 ± 0.032a | 0.233 | 0.19 ± 0.40b | 0.011 | 0.18 ± 0.40b | 0.013 | 0.008(1) |
5α-reductase (ng/L) | |||||||||||
Visit 1 | 445.90 ± 105.40 | 434.32 ± 93.76 | 441.31 ± 96.32 | 0.891(1) | |||||||
Visit 3 | 438.24 ± 98.56 | 440.40 ± 101.24 | 444.08 ± 138.16 | 0.978(1) | −7.66 ± 60.60 | 0.473 | 6.08 ± 51.46 | 0.502 | 2.77 ± 95.49 | 0.868 | 0.720(1) |
Total testosterone (ng/L) | |||||||||||
Visit 1 | 459.62 ± 131.80 | 490.54 ± 166.66 | 433.50 ± 138.80 | 0.290(1) | |||||||
Visit 3 | 454.86 ± 137.31 | 481.02 ± 151.57 | 408.44 ± 140.43 | 0.119(1) | −4.76 ± 56.96 | 0.634 | −9.52 ± 52.69 | 0.307 | −25.07 ± 37.86 | 0.001 | 0.229(1) |
Free testosterone (ng/dL) | |||||||||||
Visit 1 | 6.23 ± 1.16 | 6.26 ± 1.73 | 5.83 ± 1.31 | 0.394(1) | |||||||
Visit 3 | 6.46 ± 1.43 | 6.15 ± 1.62 | 5.64 ± 1.30 | 0.075(1) | 0.23 ± 0.77a | 0.093 | −0.11 ± 0.60ab | 0.294 | −0.19 ± 0.43b | 0.015 | 0.015(1) |