Status:
COMPLETED
H-22411: BOTOX® for Peyronie's Disease
Lead Sponsor:
Mohit Khera
Collaborating Sponsors:
Allergan
Conditions:
Peyronie's Disease
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 e...
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 pla...
Eligibility Criteria
Inclusion
- Subjects with stable Peyronie's plaques.
- Males at least 18 years of age
- Must give informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
August 7 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00812838
Start Date
August 7 2009
End Date
January 15 2019
Last Update
April 8 2024
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030