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H-22411: BOTOX® for Peyronie's Disease

NCT00812838 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-04-08

Study results available
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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

Interventions

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

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

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Mohit Khera

    lead OTHER

Principal Investigators

  • Mohit Khera, MD, MBA · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-07
Primary Completion
2017-02-15
Completion
2019-01-15

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00812838 on ClinicalTrials.gov