H-22411: BOTOX® for Peyronie's Disease
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).
|Peyronie's Disease||Drug: 100 units of Botulinum Toxin Type A Other: Preservative free normal saline||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Efficacy of Botulinum Toxin Type a in Treating Peyronie's Disease|
- Change in penile curvature [ Time Frame: End of treatment at 16 weeks ]
- Improvements in penile blood flow [ Time Frame: End of participation at 16 weeks ]
- Reduction in penile plaque size as seen on ultrasound [ Time Frame: End of participation at 16 weeks ]
- Changes in IIEF (International Index of Erectile Function) scores [ Time Frame: End of participation at 16 weeks ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Experimental: 100 units of Botulinum Toxin Type A
Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
Drug: 100 units of Botulinum Toxin Type A
Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque
Other Name: BOTOX®
Placebo Comparator: Normal saline
Injection solution will consist of 10 cc preservative free normal saline
Other: Preservative free normal saline
Approximately 20 to 30 injections of 10cc of preservative free normal saline given with a 20 gage needle directly into the penile plaque
Treatments for this disease have been limited and often unsuccessful. The goal of treatment is to reduce pain and maintain sexual function. Oral medicines that prevent plaque formation and promote plaque breakdown have not been effective. Many patients with the disease will require injections of medicines directly into the plaque. These injections have been used for over 50 years in the treatment of major Peyronie's disease. The disease often resolves on its own without treatment. Surgery may be performed to remove hardened tissue in the penis. However, surgery is not done during the first 12 months of the disease.
There are 2 phases of the disease: the active phase and the inactive phase. The active phase usually occurs during the first 12 months of the disease. The stabilization of the plaque is known as the inactive phase. We are inviting men with stable disease to take part in this study which will test BOTOX® versus a placebo (a placebo contains no medicine).
This will be a randomized, placebo-controlled, cross-over, single-center trial. Study drug is Botulinum toxin type A (BOTOX®). Subjects who meet the inclusion criteria for the study will be randomized to either the treatment or placebo arm.
- Treatment: Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline, or
- Placebo: Injection solution will consist of 10 cc preservative free normal saline.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812838
|Contact: Sharon Harrisonfirstname.lastname@example.org|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Mohit Khera, MD, MBA|
|Sub-Investigator: Larry I. Lipshultz, MD|
|Sub-Investigator: Christopher P. Smith, MD|
|Principal Investigator:||Mohit Khera, MD, MBA||Baylor College of Medicine|