Table 3.
Estimated changes from baseline in sexual function outcomes by treatment arm
| Variable | Placebo | 1 mg/day | 5 mg/day | 15 mg/day | P value (5 mg/day vs placebo) | P value (any effect) |
|---|---|---|---|---|---|---|
| PDQ-4 | ||||||
| Sexual Activity score | 0.04 (−0.36, 0.44) | 0.31 (−0.14, 0.76) | 0.09 (−0.28, 0.45) | −0.05 (−0.62, 0.53) | 0.85 | 0.73 |
| IIEF | ||||||
| Erectile Function | 2.48 (0.56, 4.40) | 1.18 (−1.05, 3.41) | −0.15 (−1.99, 1.69) | 2.92 (−0.13, 5.97) | 0.041 | 0.15 |
| Total score | 4.89 (1.16, 8.63) | 2.69 (−1.65, 7.03) | −0.40 (−3.97, 3.16) | 4.92 (−1.03, 10.9) | 0.035 | 0.16 |
| MSHQ | ||||||
| Erection | 0.64 (−0.05, 1.34) | 0.67 (−0.15, 1.50) | −0.33 (−0.97, 0.32) | 0.91 (−0.22, 2.03) | 0.037 | 0.08 |
| Ejaculation | 1.22 (−0.95, 3.39) | 2.68 (0.06, 5.30) | −0.29 (−2.35, 1.78) | −1.01 (−4.55, 2.54) | 0.30 | 0.22 |
| Satisfaction | 1.08 (−0.17, 2.33) | 1.11 (−0.36, 2.59) | −0.45 (−1.70, 0.81) | 1.00 (−1.02, 3.02) | 0.08 | 0.25 |
| DISF-M-II | 0.90 (−4.93, 6.73) | 2.56 (−4.14, 9.27) | 0.94 (−4.55, 6.44) | 3.48 (−5.40, 12.37) | 0.99 | 0.94 |
| Sexual Desire | −0.58 (−2.56, 1.41) | 0.56 (−1.76, 2.87) | −0.32 (−2.22, 1.58) | 1.69 (−1.36, 4.75) | 0.84 | 0.58 |
| Sexual Arousal | 0.42 (−0.87, 1.72) | 0.47 (−1.05, 1.98) | 0.61 (−0.62, 1.85) | 0.87 (−1.13, 2.87) | 0.83 | 0.98 |
| Sexual Activity | 0.34 (−0.94, 1.62) | 0.78 (−0.68, 2.24) | 0.53 (−0.67, 1.74) | 0.14 (−1.79, 2.08) | 0.82 | 0.95 |
| Orgasm | 0.63 (−0.94, 2.21) | 0.12 (−1.70, 1.94) | 0.30 (−1.19, 1.79) | −0.04 (−2.45, 2.38) | 0.75 | 0.96 |
| Sexual Satisfaction | 0.54 (−1.03, 2.12) | 0.89 (−0.89, 2.66) | −0.21 (−1.67, 1.26) | 0.71 (−1.65, 3.08) | 0.48 | 0.76 |
Estimates and 95% CIs extracted from mixed model framework. P values for overall dose effect and comparison between 5mg/day and placebo groups.
Abbreviations: DISF-M-II, DeRogatis Index of Sexual Function Male II; IIEF, International Index of Erectile Function; MSHQ, Male Sexual Health Questionnaire; PDQ-4, Psychosexual Daily Questionnaire 4.