H-22411: BOTOX® for Peyronie's Disease

NCT ID: NCT00812838

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-07
• Study Completion Date: 2019-01-15

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 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.

Conditions

Peyronie's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

100 units of Botulinum Toxin Type A

Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline

Group Type: EXPERIMENTAL

100 units of Botulinum Toxin Type A

Intervention Type: DRUG

Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque

Normal saline

Injection solution will consist of 10 cc preservative free normal saline

Subjects had the choice of crossing over to ARM 1 at the end of 16 weeks.

Cross-over: For subjects in Arm 2, crossover to BOTOX treatment will begin after the Week 16 Visit by repeating the study schedule as for Week 0 to Week 16.

Group Type: PLACEBO_COMPARATOR

Preservative free normal saline

Intervention Type: OTHER

Approximately 20 to 30 injections of 10cc of preservative free normal saline given with a 20 gage needle directly into the penile plaque

100 units Botulinum Toxin A

Intervention Type: DRUG

Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque

Interventions

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

Intervention Type: DRUG

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

Intervention Type: OTHER

100 units Botulinum Toxin A

Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque

Intervention Type: DRUG

Other Intervention Names

BOTOX®; Cross-over

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Mohit Khera

OTHER

Sponsor Role: lead

Responsible Party

Mohit Khera

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mohit Khera, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

Khera M, Boone TB, Smith CP. Botulinum toxin type A: a novel approach to the treatment of recurrent urethral strictures. J Urol. 2004 Aug;172(2):574-5. doi: 10.1097/01.ju.0000130652.27541.22. No abstract available.

Reference Type: BACKGROUND

PMID: 15247734 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

11-07-40-04

Identifier Type: -

Identifier Source: org_study_id