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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohit Khera, MD, MBA | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15247734 | Background | 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. |
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Data will be published in aggregate.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo Comparator | Normal saline Injection solution will consist of 10 cc preservative free normal saline. Optional 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period of 16 Weeks |
| |||||||||||||
| Optional Crossover of 16 Weeks |
|
Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
*4 subjects cross over from ARM 2 to ARM 1after 16 weeks. Crossover subjects were added to Experimental Group for analysis with Adverse Events, International Index of Erectile Function, Penile Curvature, and Reduction in Plaque Size*
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 *Crossover subjects were added to Experimental Group for analysis* |
| BG001 | Placebo Comparator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | *Crossover subjects were added to Experimental Group for analysis* | Posted | Mean | Standard Deviation | percent change | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 |
|
2 years, 8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 100 Units of Botulinum Toxin Type A | Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | Immune system disorders | Non-systematic Assessment | Cold - no treatment provided |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohit Khera, MD | Baylor College of Medicine | 713-798-6593 | mkhera@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2015 | Apr 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010411 | Penile Induration |
| ID | Term |
|---|---|
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D003434 | Crossing Over, Genetic |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| 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 |
|
| 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 |
|
|
| Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 |
| Change in Penile Blood Flow for Diameter | 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 | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 |
| Change in Penile Plaque Size | 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 | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 |
| Changes in International Index of Erectile Function Scores (IIEF) | 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 :
Subscales are not combined to make a total composite score. *Crossover subjects were added to Experimental Group for analysis* | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 |
| NOT COMPLETED |
|
Normal saline Injection solution will consist of 10 cc preservative free normal saline. Optional 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm | Count of Participants | Participants |
|
| Race (NIH/OMB) | Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Normal saline Injection solution will consist of 10 cc preservative free normal saline |
|
|
|
| Secondary | Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV) | 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 | *Penile Doppler ultrasound was not performed on optional crossover patients. Data reflects scores derived from Experimental and Placebo group analysis. | Posted | Mean | Standard Deviation | cm/s | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 |
|
|
|
|
| Secondary | Change in Penile Blood Flow for Diameter | 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 | *Penile Doppler ultrasound was not performed on optional crossover patients. Data reflects scores derived from Experimental and Placebo group analysis. | Posted | Mean | Standard Deviation | cm | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 |
|
|
|
|
| Secondary | Change in Penile Plaque Size | 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 | *Crossover subjects were added to Experimental Group for analysis* | Posted | Mean | Standard Deviation | cubic millimeters | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 |
|
|
|
|
| Secondary | Changes in International Index of Erectile Function Scores (IIEF) | 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 :
Subscales are not combined to make a total composite score. *Crossover subjects were added to Experimental Group for analysis* | *Crossover subjects were added to Experimental Group for analysis* | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 5 |
| 10 |
| EG001 | Normal Saline | Injection solution will consist of 10 cc preservative free normal saline 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 | 0 | 6 | 0 | 6 | 0 | 6 |
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | No treatment was provided |
|
| Bruising | Vascular disorders | Non-systematic Assessment | No treatment was provided |
|
| Foot pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | No treatment was provided |
|
| small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment | 1, small bowel obstruction; pain pressure in his abdomen |
|
| seasonal allergies | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | seasonal allergies |
|
| increased frequent urination | Renal and urinary disorders | Non-systematic Assessment | increased frequent urination |
|
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| D052801 |
| Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D059765 | Homologous Recombination |
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
| Pre injection Left PSV |
|
| Pre injection Left EDV |
|
| 5 minutes right PSV |
|
| 5 minutes right EDV |
|
| 5 minutes left psv |
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| 5 minutes left edv |
|
| 15 minutes right PSV |
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| 15 minutes right EDV |
|
| 15 minutes left PSV |
|
| 15 minutes left EDV |
|
| 5 minute right diameter |
|
| 5 minute left diameter |
|
| 15 minute right diameter |
|
| 15 minute left diameter |
|