Table 5.
Variable | Evaluation days | Placebo | LN18178-200 | LN18178-400 |
---|---|---|---|---|
Free Testosterone (pmol/L) | Baseline | 42.68±10.62 | 41.64±13.39 | 40.95±11.56 |
Day 7 | 41.99 ± 9.44 | 44.76 ± 12.39 (0.121*; 0.2594#) | 45.46 ± 13.29 (0.0193*; 0.1151#) | |
Day 14 | 41.64 ±12.21 | 48.23 ±16.34 (0.0115*; 0.0452#) | 51.01 ± 14.75 (0.0001*; 0.0015#) | |
Day 28 | 42.23 ± 9.79 | 53.09 ± 16.41 (<0.0001*; 0.0006#) | 54.48 ± 15.34 (<0.0001*; <0.0001#) | |
Day 56 | 43.03 ± 11.31 | 57.95 ± 18.84 (<0.0001*; <.0001#) | 60.72 ±17.73 (<0.0001*; <.0001#) | |
Total Testosterone (nmol/L) | Baseline | 12.62 ±4.84 | 12.48 ±5.47 | 13.69 ±5.13 |
Day 7 | 11.99 ± 4.50 | 12.86 ±5.28 (0.4464*; 0.2859#) | 14.95 ±6.15 (0.0512*; 0.0287#) | |
Day 14 | 11.93 ± 4.91 | 13.10 ± 5.01 (0.1564*; 0.066#) | 14.56 ± 4.91 (0.0071*; 0.0077#) | |
Day 28 | 12.41 ± 5.94 | 13.97 ± 4.75 (0.0093*; 0.0642#) | 15.49 ± 4.84 (0.0002*; 0.0071#) | |
Day 56 | 12.96 ± 5.32 | 15.15 ± 6.01 (<0.0001*; 0.0164#) | 17.05 ± 4.98 (<0.0001*; 0.0003#) | |
Dihydrotestosterone (nmol/L) | Baseline | 2.22 ± 0.77 | 2.25 ± 0.90 | 2.20 ± 0.93 |
Day 7 | 2.17 ± 0.83 | 2.24 ± 0.97 (0.921*; 0.9257#) | 2.12 ± 0.85 (0.2537*; 0.9199#) | |
Day 14 | 2.18 ± 0.85 | 2.27 ± 0.94 (0.8117*; 0.8478#) | 2.10 ± 0.85 (0.2487*; 0.819#) | |
Day 28 | 2.23 ± 0.81 | 2.32 ± 0.94 (0.4704*; 0.8448#) | 2.17 ± 0.88 (0.7256*; 0.9219#) | |
Day 56 | 2.22 ± 0.68 | 2.32 ± 0.73 (0.3151*; 0.6744#) | 2.37 ± 0.75 (0.1021*; 0.2113#) | |
Cortisol (nmol/L) | Baseline | 207.55 ± 79.10 | 198.44 ± 52.69 | 221.90 ± 98.25 |
Day 7 | 222.73 ± 69.52 | 200.65± 60.31 (0.8413*; 0.4793#) | 222.45 ± 91.19 (0.9763*; 0.9512#) | |
Day 14 | 203.96 ± 66.54 | 200.10 ± 71.32 (0.893*; 0.9998#) | 216.10 ± 99.86 (0.6984*; 0.9443#) | |
Day 28 | 214.45 ± 76.81 | 212.79 ± 67.73 (0.2384*; 0.9921#) | 211.96 ± 93.37 (0.5651*; 0.8728#) | |
Day 56 | 232.94 ± 81.72 | 228.25 ± 70.13 (0.0359*; 0.9944#) | 236.80 ± 95.41 (0.4001*; 0.9976#) | |
Estradiol (pmol/L) | Baseline | 90.86 ± 35.29 | 95.05 ± 30.45 | 91.46 ± 35.90 |
Day 56 | 92.30 ± 27.83 | 96.99 ± 25.35 (0.6541*; 0.8802#) | 93.25 ± 34.79 (0.7694*; 0.9923#) | |
Testosterone/Estradiol | Baseline | 154.90±66.70 | 132.27±55.53 | 157.65±71.64 |
Day 56 | 148.52±62.66 | 161.16±78.53 (0.0718*; 0.4442#) | 194.76±78.61 (0.0302*; 0.0012#) |
Data present as mean ± SD. Placebo (n=38), LN18178-200 (n=37), and LN18178-400 (n=40). In parentheses, * and # indicate P-values in intragroup comparison (vs. baseline) using student t-test and in intergroup comparison (vs. placebo) analyzed using ANCOVA, respectively.