Treatment of Erectile Dysfunction II
Summary
Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).
Timeline
- Start
- 2009-09
- Primary completion
- 2010-04
- Completion
- 2010-04
Outcome
Met primary endpoint
registry analysis (superiority or other test); Udenafil 50 mg vs Placebo; p <0.0001; Difference in LS Means 3.38 (95% CI 1.70 to 5.07); ANCOVA NCT01037218 ↗
registry analysis (superiority or other test); Udenafil 100 mg vs Placebo; p <0.0001; Difference in LS Means 5.74 (95% CI 4.05 to 7.43); ANCOVA NCT01037218 ↗
registry analysis (superiority or other test); Udenafil 150mg vs Placebo; p <0.0001; Difference in LS Means 7.53 (95% CI 5.86 to 9.20); ANCOVA NCT01037218 ↗
registry analysis (superiority or other test); Udenafil 50 mg vs Placebo; p <0.0001; Difference in LS Means 20.19 (95% CI 13.44 to 26.93); ANCOVA NCT01037218 ↗
registry analysis (superiority or other test); Udenafil 100 mg vs Placebo; p <0.0001; Difference in LS Means 25.06 (95% CI 18.32 to 31.81); ANCOVA NCT01037218 ↗
registry analysis (superiority or other test); Udenafil 150mg vs Placebo; p <0.0001; Difference in LS Means 32.84 (95% CI 26.18 to 39.50); ANCOVA NCT01037218 ↗
registry analysis (superiority or other test); Udenafil 50 mg vs Placebo; p <0.0001; Difference in LS Means 21.72 (95% CI 14.19 to 29.24); ANCOVA NCT01037218 ↗
registry analysis (superiority or other test); Udenafil 100 mg vs Placebo; p <0.0001; Difference in LS Means 26.82 (95% CI 19.27 to 34.37); ANCOVA NCT01037218 ↗
registry analysis (superiority or other test); Udenafil 150mg vs Placebo; p <0.0001; Difference in LS Means 35.41 (95% CI 27.98 to 42.83); ANCOVA NCT01037218 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Udenafil | Small molecule | 50 mg | Oral |
| Subject | Udenafil | Small molecule | 100 mg | Oral |
| Subject | Udenafil | Small molecule | 150 mg | Oral |