H-22411: BOTOX® for Peyronie's Disease

NCT00812838 | Completed Phase 2 Results

• 1 other identifier: 11-07-40-04
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Peyronie's Disease

Outcome Measures

Primary Outcomes (1)

• Average Percent Change of Penile Curvature in Degrees

  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

  Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16

Secondary Outcomes (4)

• Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)

  Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16

• Change in Penile Blood Flow for Diameter

  Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16

• Change in Penile Plaque Size

  Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16

• Changes in International Index of Erectile Function Scores (IIEF)

  Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16

Study Arms (2)

100 units of Botulinum Toxin Type A

EXPERIMENTAL

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

Normal saline

PLACEBO COMPARATOR

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; Drug: 100 units Botulinum Toxin A

Interventions

100 units of Botulinum Toxin Type A DRUG

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

Also known as: BOTOX®

100 units of Botulinum Toxin Type A

Preservative free normal saline OTHER

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

Normal saline

100 units Botulinum Toxin A DRUG

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

Also known as: Cross-over

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with stable Peyronie's plaques.
• Males at least 18 years of age
• Must give informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohit Khera: lead
• Allergan: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 15247734 BACKGROUND

MeSH Terms

Conditions

Penile Induration

Interventions

Botulinum Toxins, Type A; Crossing Over, Genetic

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Homologous Recombination; Recombination, Genetic; Genetic Phenomena

Results Point of Contact

• Title: Mohit Khera, MD
• Organization: Baylor College of Medicine

mkhera@bcm.edu

713-798-6593

Study Officials

• Mohit Khera, MD, MBA

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 22, 2008
• Study Start: August 7, 2009
• Primary Completion: February 15, 2017
• Study Completion: January 15, 2019
• Last Updated: April 8, 2024
• Results First Posted: February 17, 2020

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)