Treatment of Erectile Dysfunction I
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
- 2010-03
- Completion
- 2010-03
Outcome
Met primary endpoint
registry analysis (superiority or other test); Udenafil 50 mg vs Placebo; p <0.0001; Difference in Least Square (LS) Means 5.04 (95% CI 3.36 to 6.73); ANCOVA NCT01037244 ↗
registry analysis (superiority or other test); Udenafil 50 mg vs Placebo; p <0.0001; Difference in LS Means 18.60 (95% CI 11.72 to 25.48); ANCOVA NCT01037244 ↗
registry analysis (superiority or other test); Udenafil 50 mg vs Placebo; p <0.0001; Difference in LS Means 19.98 (95% CI 12.69 to 27.26); ANCOVA NCT01037244 ↗
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 |