Clinical Trial: H-22411: BOTOX® for Peyronie's Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Efficacy of Botulinum Toxin Type a in Treating Peyronie's Disease

Brief 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).


Detailed Summary:

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.

Sponsor: Mohit Khera

Current Primary Outcome: Change in penile curvature [ Time Frame: End of treatment at 16 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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 scores [ Time Frame: End of participation at 16 weeks ]


Information By: Baylor College of Medicine

Dates:
Date Received: December 18, 2008
Date Started: February 2009
Date Completion: January 2018
Last Updated: November 7, 2016
Last Verified: November 2016