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Trial record 1 of 1 for:    Open Studies | "Penile Induration"
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H-22411: BOTOX® for Peyronie's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Baylor College of Medicine
Information provided by (Responsible Party):
Mohit Khera, Baylor College of Medicine Identifier:
First received: December 18, 2008
Last updated: November 7, 2016
Last verified: November 2016

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).

Condition Intervention Phase
Peyronie's Disease
Drug: 100 units of Botulinum Toxin Type A
Other: Preservative free normal saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]

Secondary Outcome Measures:
  • Improvements in penile blood flow [ Time Frame: End of participation at 16 weeks ]
  • Reduction in penile plaque size as seen on ultrasound [ Time Frame: End of participation at 16 weeks ]
  • Changes in IIEF (International Index of Erectile Function) scores [ Time Frame: End of participation at 16 weeks ]

Estimated Enrollment: 20
Study Start Date: February 2009
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 100 units of Botulinum Toxin Type A
Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
Drug: 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
Other Name: BOTOX®
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

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. 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 identifier: NCT00812838

Contact: Sharon Harrison 713-798-2240

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
Principal Investigator: Mohit Khera, MD, MBA Baylor College of Medicine
  More Information

Responsible Party: Mohit Khera, Assistant Professor, Baylor College of Medicine Identifier: NCT00812838     History of Changes
Other Study ID Numbers: 11-07-40-04
Study First Received: December 18, 2008
Last Updated: November 7, 2016
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Data will be published in aggregate.

Additional relevant MeSH terms:
Penile Induration
Penile Diseases
Genital Diseases, Male
Connective Tissue Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents processed this record on May 22, 2017