H-22411: BOTOX® for Peyronie's Disease
Summary
Peyronie's disease is a condition in which a plaque, or hard lump, forms on the penis. It causes hardened tissue, pain, and an abnormal bending in the penis. These symptoms are more severe during an erection. Significant bending of the penis can result in pain, poor erections, and an inability to engage in sexual intercourse. This disease affects about 3% of the male population. The average age of onset of this disease is 57 years old. The cause of the disease is unknown. However, many believe that it may be due to trauma to the penis (such as injury or extremely vigorous sexual activity).
Timeline
- Start
- 2009-08-07
- Primary completion
- 2017-02-15
- Completion
- 2019-01-15
Outcome
Missed primary endpoint
registry MEAN Experimental: -21.73 (Standard Deviation 57.69) percent change MEAN Placebo Comparator: 2.429 (Standard Deviation 81.59) percent change NCT00812838 ↗
registry analysis (superiority test); Experimental vs Placebo Comparator; p = 0.5154; t-test, 2 sided NCT00812838 ↗
Publications
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 100 iu | Other |