Trial · NCT00812838
H-22411: BOTOX® for Peyronie's Disease
NCT00812838, Phase 2, Completed, Mohit Khera; results first posted 2020-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. H-22411: BOTOX® for Peyronie's Disease. Trials, record NCT00812838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00812838
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- H-22411: BOTOX® for Peyronie's Disease
- NCT number
- NCT00812838
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Mohit Khera
- Conditions
- Peyronie's Disease
- Interventions
- 100 units of Botulinum Toxin Type A, Preservative free normal saline, 100 units Botulinum Toxin A
- First posted
- 2008-12-22
- Last updated
- 2024-04-08
- Results first posted
- 2020-02-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Percent Change of Penile Curvature in Degrees | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 | 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 |
| Secondary | 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 | 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 |
| Secondary | Change in Penile Blood Flow for Diameter | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 | 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 |
| Secondary | Change in Penile Plaque Size | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 | 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 |
| Secondary | Changes in International Index of Erectile Function Scores (IIEF) | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 | 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 : 1. Orgasmic Function (Questions 9, 10); Maximum score = 10, Minimum score = 0 2. Sexual Desire (Questions 11, 12); Maximum score = 10, Minimum score = 0 3. Intercourse Satisfaction (Questions 6, 7, 8); Maximum score = 15, Minimum score = 0 4. Overall Satisfaction (Question 13, 14): Maximum score = 10, Minimum score = 0 Subscales are not combined to make a total composite score. \*Crossover subjects were added to Experimental Group for analysis\* |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Percent Change of Penile Curvature in Degrees | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 | \*Crossover subjects were added to Experimental Group for analysis\* | percent change | MEAN |
| SECONDARY | 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 | \*Penile Doppler ultrasound was not performed on optional crossover patients. Data reflects scores derived from Experimental and Placebo group analysis. | cm/s | MEAN |
| SECONDARY | Change in Penile Blood Flow for Diameter | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 | \*Penile Doppler ultrasound was not performed on optional crossover patients. Data reflects scores derived from Experimental and Placebo group analysis. | cm | MEAN |
| SECONDARY | Change in Penile Plaque Size | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 | \*Crossover subjects were added to Experimental Group for analysis\* | cubic millimeters | MEAN |
| SECONDARY | Changes in International Index of Erectile Function Scores (IIEF) | Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 | \*Crossover subjects were added to Experimental Group for analysis\* | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Percent Change of Penile Curvature in Degrees | Experimental | -21.73 | Standard Deviation 57.69 | percent change | |
| Average Percent Change of Penile Curvature in Degrees | Placebo Comparator | 2.429 | Standard Deviation 81.59 | percent change | |
| Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV) | 100 Units of Botulinum Toxin Type A | Pre injection Right PSV | -0.65670 | Standard Deviation 5.505 | cm/s |
| Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV) | Normal Saline | Pre injection Right PSV | -9.0170 | Standard Deviation 11.43 | cm/s |
| Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV) | 100 Units of Botulinum Toxin Type A | Pre injection Right EDV | -2.10200 | Standard Deviation 6.798 | cm/s |
| Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV) | Normal Saline | Pre injection Right EDV | -0.8667 | Standard Deviation 3.771 | cm/s |
| Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV) | 100 Units of Botulinum Toxin Type A | Pre injection Left PSV | -1.263 | Standard Deviation 9.032 | cm/s |
| Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV) | Normal Saline | Pre injection Left PSV | -6.4330 | Standard Deviation 12.04 | cm/s |
| Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV) | 100 Units of Botulinum Toxin Type A | Pre injection Left EDV | -10.27 | Standard Deviation 8.261 | cm/s |
| Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV) | Normal Saline | Pre injection Left EDV | -6.75 | Standard Deviation 11.63 | cm/s |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period of 16 Weeks | STARTED | Experimental | 6 | |
| Treatment Period of 16 Weeks | STARTED | Placebo Comparator | 6 | |
| Treatment Period of 16 Weeks | COMPLETED | Experimental | 6 | |
| Treatment Period of 16 Weeks | COMPLETED | Placebo Comparator | 6 | |
| Treatment Period of 16 Weeks | NOT COMPLETED | Experimental | 0 | |
| Treatment Period of 16 Weeks | NOT COMPLETED | Placebo Comparator | 0 | |
| Optional Crossover of 16 Weeks | STARTED | Experimental | 0 | |
| Optional Crossover of 16 Weeks | STARTED | Placebo Comparator | 4 | |
| Optional Crossover of 16 Weeks | COMPLETED | Experimental | 0 | |
| Optional Crossover of 16 Weeks | COMPLETED | Placebo Comparator | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cold | Immune system disorders | 100 Units of Botulinum Toxin Type A | 2 | 10 | 2 |
| other | Cold | Immune system disorders | Normal Saline | 0 | 6 | 0 |
| other | back pain | Musculoskeletal and connective tissue disorders | 100 Units of Botulinum Toxin Type A | 1 | 10 | 1 |
| other | back pain | Musculoskeletal and connective tissue disorders | Normal Saline | 0 | 6 | 0 |
| other | Bruising | Vascular disorders | 100 Units of Botulinum Toxin Type A | 2 | 10 | 2 |
| other | Bruising | Vascular disorders | Normal Saline | 0 | 6 | 0 |
| other | Foot pain | Musculoskeletal and connective tissue disorders | 100 Units of Botulinum Toxin Type A | 1 | 10 | 1 |
| other | Foot pain | Musculoskeletal and connective tissue disorders | Normal Saline | 0 | 6 | 0 |
| other | small bowel obstruction | Gastrointestinal disorders | 100 Units of Botulinum Toxin Type A | 1 | 10 | 1 |
| other | small bowel obstruction | Gastrointestinal disorders | Normal Saline | 0 | 6 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 100 Units of Botulinum Toxin Type A | 0 | 10 |
| Total, all-cause mortality | Normal Saline | 0 | 6 |
| Total, other adverse events | 100 Units of Botulinum Toxin Type A | 5 | 10 |
| Total, other adverse events | Normal Saline | 0 | 6 |
| Total, serious adverse events | 100 Units of Botulinum Toxin Type A | 0 | 10 |
| Total, serious adverse events | Normal Saline | 0 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 15247734 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 100 Units of Botulinum Toxin Type A vs Normal Saline: deaths from any cause | Trial comparisons |
| 100 Units of Botulinum Toxin Type A vs Normal Saline: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00812838
GET https://conductscience.org/api/trials/v1/NCT00812838/results?page=2