H-22411: BOTOX® for Peyronie's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Baylor College of Medicine
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Mohit Khera, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00812838
First received: December 18, 2008
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.

  • 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.

Condition Intervention Phase
Peyronie's Disease
Drug: 100 units of BOTOX®
Other: Preservative free normal saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Botulinum Toxin Type a in Treating Peyronie's Disease

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Change in penile curvature [ Time Frame: End of treatment at 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvements in penile blood flow [ Time Frame: End of participation at 16 weeks ] [ Designated as safety issue: No ]
  • Reduction in penile plaque size as seen on ultrasound [ Time Frame: End of participation at 16 weeks ] [ Designated as safety issue: No ]
  • Changes in IIEF (International Index of Erectile Function) scores [ Time Frame: End of participation at 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2009
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BOTOX®
Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
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
Other Name: Botulinum Toxin Type A, Purified Neurotoxin Complex, Clostridium botulinum type A neurotoxin complex
Placebo Comparator: Normal saline
Injection solution will consist of 10 cc preservative free normal saline
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 Trentol, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812838

Contacts
Contact: Sharon Harrison 713-798-2240 sharons@bcm.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Mohit Khera, MD, MBA         
Sub-Investigator: Larry I. Lipshultz, MD         
Sub-Investigator: Christopher P. Smith, MD         
Sponsors and Collaborators
Mohit Khera
Allergan
Investigators
Principal Investigator: Mohit Khera, MD, MBA Baylor College of Medicine
  More Information

Publications:
Responsible Party: Mohit Khera, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00812838     History of Changes
Other Study ID Numbers: 11-07-40-04
Study First Received: December 18, 2008
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Penile Induration
Connective Tissue Diseases
Genital Diseases, Male
Penile Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014