Table 3.
Assessment of International Index of Erectile Function scores (IIEF) & Erection Hardness Scores (EHS)
| 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) | |
|---|---|---|---|---|---|---|---|
| IIEF- Erectile function | |||||||
| Placebo | Baseline | 17.80 ± 0.98 | - | - | - | - | - |
| Day 14 | 18.22 ± 1.47 | 0.0722 | - | -0.04, 0.88 | - | - | |
| Day 42 | 18.78 ± 1.47 | < 0.0001 | - | 0.52, 1.44 | - | - | |
| Day 84 | 20.44 ± 1.67 | < 0.0001 | - | 2.14, 3.14 | - | - | |
| LN18178 | Baseline | 17.81 ± 0.81 | 0.9341 | - | -0.32, 0.34 | - | |
| Day 14 | 20.07 ± 1.49 | < 0.0001 | < 0.0001 | 1.81, 2.71 | 1.31, 2.39 | < 0.0001 | |
| Day 42 | 22.28 ± 1.71 | < 0.0001 | < 0.0001 | 3.97, 4.97 | 2.91, 4.09 | < 0.0001 | |
| Day 84 | 25.54 ± 1.73 | < 0.0001 | < 0.0001 | 7.23, 8.23 | 4.47, 5.73 | < 0.0001 | |
| IIEF- Orgasmic function | |||||||
| Placebo | Baseline | 4.88 ± 1.02 | - | - | - | - | - |
| Day 14 | 5.1 ± 0.86 | 0.0459 | - | -0.12, 0.56 | - | - | |
| Day 42 | 5.85 ± 0.89 | < 0.0001 | - | 0.62, 1.32 | - | - | |
| Day 84 | 7.12 ± 0.91 | < 0.0001 | - | 1.89, 2.59 | - | - | |
| LN18178 | Baseline | 4.67 ± 0.83 | 0.1491 | - | -0.13, 0.55 | - | |
| Day 14 | 5.77 ± 1.09 | < 0.0001 | < 0.0001 | 0.74, 1.46 | 0.31, 1.03 | <0.0001 | |
| Day 42 | 6.79 ± 0.77 | < 0.0001 | < 0.0001 | 1.82, 2.42 | 0.63, 1.25 | <0.0001 | |
| Day 84 | 8.81 ± 0.72 | < 0.0001 | < 0.0001 | 3.85, 4.43 | 1.39, 1.99 | <0.0001 | |
| IIEF- Sexual desire | |||||||
| Placebo | Baseline | 3.71 ± 0.87 | - | - | - | - | - |
| Day 14 | 4.81 ± 1.14 | < 0.0001 | - | 0.73, 1.47 | - | ||
| Day 42 | 5.47 ± 0.92 | < 0.0001 | - | 1.43, 2.09 | - | - | |
| Day 84 | 6.64 ± 1 | < 0.0001 | - | 2.59, 3.27 | - | - | |
| LN18178 | Baseline | 3.86 ± 0.77 | 0.2635 | - | -0.15, 0.45 | - | |
| Day 14 | 5.65 ± 0.81 | < 0.0001 | < 0.0001 | 1.50, 2.08 | 0.48, 1.20 | 0.0014 | |
| Day 42 | 6.81 ± 0.67 | < 0.0001 | < 0.0001 | 2.68, 3.22 | 1.04, 1.64 | < 0.0001 | |
| Day 84 | 8.6 ± 0.88 | < 0.0001 | < 0.0001 | 4.43, 5.05 | 1.61, 2.30 | < 0.0001 | |
| IIEF- Intercourse satisfaction | |||||||
| Placebo | Baseline | 6.97 ± 1.33 | - | - | - | - | - |
| Day 14 | 7.32 ± 1.29 | 0.0149 | -0.13, 0.83 | - | |||
| Day 42 | 8.85 ± 1.26 | < 0.0001 | - | 1.41, 2.35 | - | - | |
| Day 84 | 10.64 ± 1.24 | < 0.0001 | - | 3.20, 4.14 | - | - | |
| LN18178 | Baseline | 6.6 ± 1.36 | 0.1237 | - | -0.12, 0.86 | - | |
| Day 14 | 8.25 ± 1.81 | < 0.0001 | < 0.0001 | 1.06, 2.24 | 0.35, 1.51 | < 0.0001 | |
| Day 42 | 10.33 ± 1.27 | < 0.0001 | < 0.0001 | 3.24, 4.22 | 1.01, 1.95 | < 0.0001 | |
| Day 84 | 12.74 ± 1.06 | < 0.0001 | < 0.0001 | 5.69, 6.59 | 1.68, 2.53 | < 0.0001 | |
| IIEF- Overall satisfaction | |||||||
| Placebo | Baseline | 4.63 ± 0.98 | - | - | - | - | - |
| Day 14 | 5.1 ± 0.84 | < 0.0001 | - | 0.14, 0.80 | - | - | |
| Day 42 | 6.17 ± 0.85 | < 0.0001 | - | 1.21, 1.87 | - | - | |
| Day 84 | 6.8 ± 0.89 | < 0.0001 | - | 1.83, 2.51 | - | - | |
| LN18178 | Baseline | 4.49 ± 1.05 | 0.3834 | - | -0.23, 0.51 | - | |
| Day 14 | 5.63 ± 1.14 | < 0.0001 | 0.0004 | 0.73, 1.55 | 0.16, 0.90 | 0.0026 | |
| Day 42 | 7.04 ± 0.73 | < 0.0001 | < 0.0001 | 2.21, 2.89 | 0.58, 1.16 | < 0.0001 | |
| Day 84 | 8.68 ± 0.74 | < 0.0001 | < 0.0001 | 3.85, 4.53 | 1.58, 2.18 | < 0.0001 | |
| IIEF- Total score | |||||||
| Placebo | Baseline | 37.98 ± 3.07 | - | - | - | - | |
| Day 14 | 40.56 ± 3.59 | < 0.0001 | - | 1.36, 3.80 | - | ||
| Day 42 | 45.12 ± 3.13 | < 0.0001 | - | 6.01, 8.27 | - | ||
| Day 84 | 51.64 ± 3.31 | < 0.0001 | - | 12.50, 14.82 | - | ||
| LN18178 | Baseline | 37.42 ± 2.66 | 0.2511 | -0.5, 1.62 | - | ||
| Day 14 | 45.37 ± 4.74 | < 0.0001 | < 0.0001 | 6.52, 9.38 | 3.27, 6.35 | < 0.0001 | |
| Day 42 | 53.25 ± 3.33 | < 0.0001 | < 0.0001 | 14.71, 16.95 | 6.94, 9.32 | < 0.0001 | |
| Day 84 | 64.37 ± 3.09 | < 0.0001 | < 0.0001 | 25.88, 28.02 | 11.55, 13.91 | < 0.0001 | |
| EHS scores | |||||||
| Placebo | Baseline | 1.97 ± 0.61 | - | - | - | ||
| Day 14 | 1.98 ± 0.68 | 0.9813 | - | -0.23, 0.25 | - | ||
| Day 42 | 2.08 ± 0.6 | 0.2453 | -0.11, 0.33 | ||||
| Day 84 | 2.12 ± 0.74 | 0.2233 | - | -0.10, 0.40 | - | ||
| LN18178 | Baseline | 2.02 ± 0.67 | 0.6632 | -0.19, 0.29 | - | ||
| Day 14 | 2.47 ± 0.57 | < 0.0001 | < 0.0001 | 0.22, 0.68 | 0.26, 0.72 | 0.0079 | |
| Day 42 | 3.12 ± 0.71 | < 0.0001 | < 0.0001 | 0.84, 1.36 | 0.80, 1.28 | < 0.0001 | |
| Day 84 | 3.65 ± 0.48 | < 0.0001 | <0.0001 | 1.41, 1.85 | 1.30, 1.76 | < 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.