H-22411: BOTOX® for Peyronie's Disease
Condition: Peyronie's Disease
MeSH terms: Penile Induration
Intervention: 100 units of Botulinum Toxin Type A; Preservative free normal saline; 100 units Botulinum Toxin A
Intervention description: Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque; Approximately 20 to 30 injections of 10cc of preservative free normal saline given with a 20 gage needle directly into the penile plaque; Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with stable Peyronie's plaques.

          -  Males at least 18 years of age

          -  Must give informed consent.

        Exclusion Criteria:

          -  Subjects in the active phase of Peyronie's disease.

          -  Subjects with less than 1 year history of Peyronie's disease.

          -  Subjects taking oral medications for Peyronie's disease which include Trental, Viagra,
             vitamin E, colchicines, L-arginine, and tamoxifen. There will be a 2 week wash-out
             period if patients are on these medications.

          -  Subjects with more than 1 penile plaque will be excluded from the study.

          -  Subjects with calcified plaques demonstrated by ultrasound will be excluded from the
             study.

          -  Known allergy or sensitivity to any components of the study medication (botulinum
             toxin A), anesthetics, or any other product associated with the treatment and general
             study procedures.

          -  Any medical condition or neuromuscular disorder that may put the patient at increased
             risk with exposure to botulinum toxin A (BTX-A), including myasthenia gravis,
             Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.

          -  Patient taking aminoglycosides or any drug known to interfere with neuromuscular
             transmission.

          -  Patient has hemophilia or other clotting factor deficiencies or disorders that cause
             bleeding diathesis.

          -  Patient must not be taking aspirin, non-steroidal anti-inflammatory drugs, or Coumadin
             for 7 or more days prior to Botox injection.

          -  Episode of unstable angina pectoris, myocardial infarction, transient ischemic attack,
             or cerebrovascular accident within the past 6 months.