Table 2.
Assessment of DISF-SR-M scores
| Evaluation | Mean ± SD | P value (vs. baseline) | P value (vs. placebo) | 95% CI vs. Baseline | 95% CI vs. Placebo | P value, change from baseline (vs. placebo) | |
|---|---|---|---|---|---|---|---|
| Sexual cognition | |||||||
| Placebo | Baseline | 11.64 ± 2.77 | - | - | - | - | - |
| Day 14 | 12.69 ± 2.45 | < 0.0001 | - | 0.10, 2.00 | - | - | |
| Day 42 | 12.37 ± 2.37 | 0.0287 | - | -0.21, 1.67 | - | - | |
| Day 84 | 14.41 ± 3.92 | < 0.0001 | - | 1.53, 4.01 | - | - | |
| LN18178 | Baseline | 12.07 ± 2.08 | - | 0.4120 | - | -0.47, 1.33 | - |
| Day 14 | 15.04 ± 3.01 | < 0.0001 | < 0.0001 | 2.01, 3.93 | 1.34, 3.36 | < 0.0001 | |
| Day 42 | 17.88 ± 2.54 | < 0.0001 | < 0.0001 | 4.95, 6.67 | 4.61, 6.41 | < 0.0001 | |
| Day 84 | 26.21 ± 2.79 | < 0.0001 | < 0.0001 | 13.23, 15.05 | 10.54, 13.06 | < 0.0001 | |
| Sexual arousal | |||||||
| Placebo | Baseline | 10.98 ± 3.03 | - | - | - | - | - |
| Day 14 | 12.05 ± 2.35 | < 0.0001 | - | 0.08, 2.06 | - | - | |
| Day 42 | 15.08 ± 2.52 | < 0.0001 | - | 3.08, 5.12 | - | - | |
| Day 84 | 15.20 ± 2.5 | < 0.0001 | - | 3.21, 5.23 | - | - | |
| LN18178 | Baseline | 10.91 ± 3.01 | - | 0.8999 | - | -1.04, 1.18 | - |
| Day 14 | 14.58 ± 3.01 | < 0.0001 | < 0.0001 | 2.55, 4.79 | 1.54, 3.52 | < 0.0001 | |
| Day 42 | 18.39 ± 2.88 | < 0.0001 | < 0.0001 | 6.39, 8.57 | 2.32, 4.30 | < 0.0001 | |
| Day 84 | 26.54 ± 2.8 | < 0.0001 | < 0.0001 | 14.55, 16.71 | 10.36, 12.32 | < 0.0001 | |
| Sexual behaviour | |||||||
| Placebo | Baseline | 10.54 ± 2.36 | - | - | - | - | - |
| Day 14 | 12.02 ± 1.94 | < 0.0001 | - | 0.69, 2.27 | - | ||
| Day 42 | 15.17 ± 2.21 | < 0.0001 | - | 3.80, 5.46 | - | - | |
| Day 84 | 15.08 ± 1.99 | < 0.0001 | - | 3.74, 5.34 | - | - | |
| LN18178 | Baseline | 10.12 ± 2.88 | - | 0.3916 | - | -0.55, 1.39 | - |
| Day 14 | 13.53 ± 2.67 | < 0.0001 | < 0.0001 | 2.38, 4.44 | 0.65, 2.37 | < 0.0001 | |
| Day 42 | 17.54 ± 2.24 | < 0.0001 | < 0.0001 | 6.46, 8.38 | 1.55, 3.19 | < 0.0001 | |
| Day 84 | 26.12 ± 2.54 | < 0.0001 | < 0.0001 | 14.99, 17.01 | 10.20, 11.88 | < 0.0001 | |
| Orgasm | |||||||
| Placebo | Baseline | 11.32 ± 2.87 | - | - | - | - | |
| Day 14 | 12.64 ± 3.23 | < 0.0001 | 0.21, 2.43 | - | |||
| Day 42 | 13.75 ± 3.06 | < 0.0001 | - | 1.35, 3.51 | - | - | |
| Day 84 | 17.39 ± 2.29 | < 0.0001 | - | 5.12, 7.02 | - | - | |
| LN18178 | Baseline | 11.56 ± 3.05 | 0.6644 | - | -0.85, 1.33 | - | |
| Day 14 | 13.81 ± 2.46 | <0.0001 | <0.0001 | 1.22, 3.28 | -0.60, 1.52 | 0.0018 | |
| Day 42 | 15.16 ± 2.22 | <0.0001 | 0.0018 | 2.61, 4.59 | 0.42, 2.40 | 0.0195 | |
| Day 84 | 20.88 ± 2.01 | <0.0001 | <0.0001 | 8.36, 10.28 | <0.0001 | ||
| Sexual drive | |||||||
| Placebo | Baseline | 8.97 ± 1.61 | - | - | - | - | - |
| Day 14 | 10.34 ± 1.94 | <0.0001 | - | 0.72, 2.02 | - | - | |
| Day 42 | 11.05 ± 1.98 | <0.0001 | - | 1.42, 2.74 | - | - | |
| Day 84 | 14.05 ± 2.37 | <0.0001 | - | 4.34, 5.82 | - | - | |
| LN18178 | Baseline | 8.49 ± 1.91 | 0.1496 | - | -0.17, 1.13 | - | |
| Day 14 | 10.95 ± 1.85 | <0.0001 | 0.00411 | 1.76, 3.16 | -0.09, 1.31 | 0.0004 | |
| Day 42 | 14.56 ± 2.08 | <0.0001 | <0.0001 | 5.33, 6.81 | 2.76, 4.26 | <0.0001 | |
| Day 84 | 18.23 ± 1.6 | <0.0001 | <0.0001 | 9.09, 10.39 | 3.43, 4.93 | <0.0001 | |
| Total score | |||||||
| Placebo | Baseline | 53.46 ± 9.25 | - | - | - | - | - |
| Day 14 | 59.75 ± 8.18 | <0.0001 | - | 4.81, 10.53 | - | - | |
| Day 42 | 67.42 ± 7.47 | <0.0001 | - | 10.89, 17.03 | - | - | |
| Day 84 | 76.14 ± 7.22 | <0.0001 | - | 13.58, 19.20 | - | - | |
| LN18178 | Baseline | 53.16 ± 10.34 | 0.8694 | - | -3.31, 3.91 | - | |
| Day 14 | 67.89 ± 10.37 | <0.0001 | <0.0001 | 10.89, 18.57 | 4.71, 11.57 | <0.0001 | |
| Day 42 | 83.53 ± 8.16 | <0.0001 | <0.0001 | 26.91, 33.83 | 13.23, 18.99 | <0.0001 | |
| Day 84 | 117.98 ± 9.56 | <0.0001 | <0.0001 | 61.12, 68.52 | 38.73, 44.95 | <0.0001 | |
| Morning erection (Q 2.1) | |||||||
| Placebo | Baseline | 2.34 ± 0.92 | - | - | - | - | - |
| Day 14 | 2.53 ± 0.73 | 0.0245 | - | -0.11, 0.49 | - | - | |
| Day 42 | 3.02 ± 0.75 | < 0.0001 | - | 0.37, 0.99 | - | - | |
| Day 84 | 2.95 ± 0.86 | < 0.0001 | - | 0.29, 0.93 | - | - | |
| LN18178 | Baseline | 2.19 ± 0.95 | - | - | - | -0.19, 0.49 | - |
| Day 14 | 3.04 ± 0.84 | < 0.0001 | < 0.0001 | 0.52, 1.18 | 0.22, 0.80 | < 0.0001 | |
| Day 42 | 3.58 ± 1.02 | < 0.0001 | 0.0004 | 1.02, 1.76 | 0.23, 0.89 | 0.0009 | |
| Day 84 | 5.26 ± 0.81 | < 0.0001 | < 0.0001 | 2.74, 3.40 | 2.00, 2.62 | < 0.0001 | |
| Sexual activity (Q 3.5) | |||||||
| Placebo | Baseline | 2.22 ± 0.91 | - | - | - | - | - |
| Day 14 | 2.63 ± 0.72 | < 0.0001 | - | 0.11, 0.71 | - | - | |
| Day 42 | 3.22 ± 0.85 | < 0.0001 | - | 0.68, 1.32 | - | - | |
| Day 84 | 3.22 ± 0.67 | < 0.0001 | - | 0.71, 1.29 | - | - | |
| LN18178 | Baseline | 2.28 ± 0.96 | - | - | - | -0.28, 0.40 | - |
| Day 14 | 2.95 ± 0.88 | < 0.0001 | 0.0186 | 0.33, 1.01 | 0.03, 0.61 | 0.0738 | |
| Day 42 | 3.88 ± 0.87 | < 0.0001 | < 0.0001 | 1.26, 1.94 | 0.34, 0.98 | 0.0097 | |
| Day 84 | 5.37 ± 0.75 | < 0.0001 | < 0.0001 | 2.77, 3.41 | 1.89, 2.41 | < 0.0001 | |
Values present mean ± SD. placebo (n=59) and LN18178 (n=57). CI: Confidence interval; P < 0.05 was considered as statistically significant for 'within the group' and 'between the groups' comparison analysis using paired t test and ANCOVA, respectively, as described in materials and methods.