The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease
Summary
This study evaluated the safety and effectiveness of AA4500 in improving the impact of Peyronie's disease on quality of life and improving penile curvature in men with Peyronie's disease
Timeline
- Start
- 2008-08
- Primary completion
- 2009-12
- Completion
- 2009-12
Outcome
Mixed primary results
registry MEAN AA4500: -29.7 (Standard Deviation 27.16) Percent change from baseline NCT00755222 ↗
registry Negative change reflects improvement in penile curvature NCT00755222 ↗
registry analysis (superiority or other test); AA4500 vs Placebo; p = 0.001; ANOVA NCT00755222 ↗
registry MEAN AA4500: -2.6 (Standard Deviation 4.63) scores on a scale NCT00755222 ↗
registry MEAN Placebo: -0.8 (Standard Deviation 3.63) scores on a scale NCT00755222 ↗
registry analysis (superiority or other test); AA4500 vs Placebo; p = 0.046; ANOVA NCT00755222 ↗
registry analysis (superiority or other test); AA4500 vs Placebo; p = 0.164; ANOVA NCT00755222 ↗
registry analysis (superiority or other test); AA4500 vs Placebo; p = 0.442; ANOVA NCT00755222 ↗
registry analysis (superiority or other test); AA4500 vs Placebo; p = 0.095; ANOVA NCT00755222 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Collagenase Clostridium Histolyticum | Protein / enzyme biologic | — | Other |