H-22411: BOTOX® for Peyronie's Disease

Status Completed

Clinical Trial 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).

Clinical Trial Description

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. The placebo group has the option to cross over to the treatment arm (ARM 1) of the study at the end of their 16 weeks of placebo arm (ARM 2). 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00812838
Study type	Interventional
Source	Baylor College of Medicine
Contact
Status	Completed
Phase	Phase 2
Start date	August 7, 2009
Completion date	January 15, 2019

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT01430169` - Pharmacokinetics of a Single Treatment Cycle of AA4500 0.58 mg in Men With Peyronie's Disease	Phase 2
Completed	`NCT01221597` - Study of AA4500 in the Treatment of Peyronie's Disease	Phase 3
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Completed	`NCT02267460` - An Open-label Study to Assess the Safety and Effectiveness of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Treating Men With Peyronie's Disease	Phase 3
Completed	`NCT01221623` - Study of AA4500 in the Treatment of Peyronie's Disease	Phase 3
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Completed	`NCT01243411` - A Study of AA4500 in Men With Peyronie's Disease	Phase 3
Completed	`NCT01578473` - Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease	Phase 1
Not yet recruiting	`NCT05855070` - Intralesional Hyaluronic Acid and Verapamil Injection in Peyronie's Disease	N/A
Completed	`NCT02072018` - Peyronie's Disease Treatment Protocol	Phase 1
Terminated	`NCT05873595` - Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease
Active, not recruiting	`NCT04786106` - Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's	Phase 4
Completed	`NCT02395029` - Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of PD	Phase 1
Completed	`NCT00755222` - The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.