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H-22411: BOTOX® for Peyronie's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00812838
Recruitment Status : Completed
First Posted : December 22, 2008
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Mohit Khera, Baylor College of Medicine

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).


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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Botulinum Toxin Type a in Treating Peyronie's Disease
Actual Study Start Date : August 7, 2009
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
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

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.

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

Drug: 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
Other Name: Cross-over




Primary Outcome Measures :
  1. Average Percent Change of Penile Curvature in Degrees [ Time Frame: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 ]

    Measured by a protractor from pictures taken at baseline (pre-treatment screening visit) and end of treatment at week 16

    *Crossover subjects were added to Experimental Group for analysis*

    Negative value equates to a reduction in curvature Positive value equates to an increase in curvature



Secondary Outcome Measures :
  1. Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV) [ Time Frame: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 ]

    Results of penile doppler ultrasound from baseline/screening visit to end of treatment at week 16 will be compared.

    peak systolic velocity (PSV) and end-diastolic velocity (EDV) are assessed here.

    Change is calculated as week 16 values - screening visit values

    Negative values are a decrease in velocity Positive values are an increase in velocity


  2. Change in Penile Blood Flow for Diameter [ Time Frame: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 ]

    Results of penile doppler ultrasound from the baseline/screening visit to end of treatment at week 16 will be compared.

    Diameter is assessed here.

    Change is calculated as week 16 values - screening visit values

    Negative values are a decrease in diameter Positive values are an increase in diameter


  3. Change in Penile Plaque Size [ Time Frame: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 ]

    Results of ultrasound at baseline/screening visit to end of treatment at week 16 will be compared.

    *Crossover subjects were added to Experimental Group for analysis*

    Change is calculated as week 16 values values minus screening visit values

    Increase in value equates to increased plaque size Decrease in value equates to decreased plaque size


  4. Changes in International Index of Erectile Function Scores (IIEF) [ Time Frame: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 ]

    Subject's average scores on IIEF at baseline/screening visit to end of treatment at week 16 are compared

    The subscale measures self-reported erectile function. Maximum score is 30, Minimum is 0. A score of 0 is the absolute best outcome. A score of 30 is the absolute worst outcome. Erectile Function score is a summation of questions 1,2,3,4, and 15. This study is assessing their erectile function and not the other subscales.

    The other subscale scores are :

    1. Orgasmic Function (Questions 9, 10); Maximum score = 10, Minimum score = 0
    2. Sexual Desire (Questions 11, 12); Maximum score = 10, Minimum score = 0
    3. Intercourse Satisfaction (Questions 6, 7, 8); Maximum score = 15, Minimum score = 0
    4. Overall Satisfaction (Question 13, 14): Maximum score = 10, Minimum score = 0

    Subscales are not combined to make a total composite score.

    *Crossover subjects were added to Experimental Group for analysis*




Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812838


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Mohit Khera
Allergan
Investigators
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Principal Investigator: Mohit Khera, MD, MBA Baylor College of Medicine
  Study Documents (Full-Text)

Documents provided by Mohit Khera, Baylor College of Medicine:
Publications:
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Responsible Party: Mohit Khera, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00812838    
Other Study ID Numbers: 11-07-40-04
First Posted: December 22, 2008    Key Record Dates
Results First Posted: February 17, 2020
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be published in aggregate.
Additional relevant MeSH terms:
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Penile Induration
Penile Diseases
Genital Diseases, Male
Connective Tissue Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
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