Phase 2
N=12
H-22411: BOTOX® for Peyronie's Disease
Peyronie's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00812838 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Average Percent Change of Penile Curvature in Degrees — -21.73; 2.429 percent change — p=0.5154
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 100 units of Botulinum Toxin Type A (Drug); Preservative free normal saline (Other); 100 units Botulinum Toxin A (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Mohit Khera
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Percent Change of Penile Curvature in Degrees |
-21.73; 2.429 | 0.5154 |
| SECONDARY Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV) |
-0.65670; -9.0170; -2.10200; -0.8667; -1.263; -6.4330 | 0.3009 |
| SECONDARY Change in Penile Blood Flow for Diameter |
-0.29; 0.1700; 0.04167; 0.3983; 1.34200; 0.2917 | 0.0166 sig |
| SECONDARY Change in Penile Plaque Size |
717.5; 485.8; 198.9; 319.0 | .8566 |
| SECONDARY Changes in International Index of Erectile Function Scores (IIEF) |
15.60; 21; 17.20; 21.50 | 0.0286 sig |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00812838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.