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Sponsors and Collaborators: |
Baylor College of Medicine Allergan |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00812838 |
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).
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.
Condition | Intervention | Phase |
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Peyronie's Disease |
Drug: 100 units of BOTOX® Other: Preservative free normal saline |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety Study |
Official Title: | The Efficacy of Botulinum Toxin Type a in Treating Peyronie's Disease |
Estimated Enrollment: | 20 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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BOTOX®: Experimental
Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
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Drug: 100 units of BOTOX®
Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque
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Normal saline: Placebo Comparator
Injection solution will consist of 10 cc preservative free normal saline
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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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mohit Khera, MD, MBA | 713-798-4001 | mkhera@bcm.edu |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Mohit Khera, MD, MBA | Baylor College of Medicine |
Responsible Party: | Scott Department of Urology, Baylor College of Medicine ( Mohit Khera, MD, MBA ) |
Study ID Numbers: | 04-07-30-02 |
Study First Received: | December 18, 2008 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00812838 |
Health Authority: | United States: Food and Drug Administration |
Penile Induration Botulinum Toxins Peyronie disease |
Connective Tissue Diseases Botulinum Toxin Type A Genital Diseases, Male |
Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Neuromuscular Agents |
Peripheral Nervous System Agents Central Nervous System Agents Penile Diseases Pharmacologic Actions |