Trial · NCT01221597
Study of AA4500 in the Treatment of Peyronie's Disease
NCT01221597, Phase 3, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2015-04-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of AA4500 in the Treatment of Peyronie's Disease. Trials, record NCT01221597. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01221597
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of AA4500 in the Treatment of Peyronie's Disease
- NCT number
- NCT01221597
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 418 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Peyronie's Disease
- Interventions
- AA4500, Placebo
- First posted
- 2010-10-15
- Last updated
- 2017-10-05
- Results first posted
- 2015-04-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline in Penile Curvature | Baseline and Week 52 | A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature. |
| Primary | Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) | Baseline and Week 52 | Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number. |
| Secondary | A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease | Week 52 | A responder was defined as a subject who recorded his Peyronie's disease had either improved in a small but important way, moderately improved, or much improved in overall global assessment question. |
| Secondary | Change From Baseline in the Severity of Peyronie's Disease Physical and Psychological Symptoms | Baseline and Week 52 | Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number. |
| Secondary | Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF) | Baseline and Week 52 | Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10. |
| Secondary | Change From Baseline in Penile Plaque Consistency | Baseline and Week 52 | Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline score in penile plaque consistency is indicated by a negative number. |
| Secondary | Change From Baseline in Penile Length | Baseline and Week 52 | A negative value represents a reduction in measurement from baseline. |
| Secondary | Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4 | Baseline and Week 52 | Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline. |
| Secondary | Composite Responder Based on Change in Curvature Deformity and Change in Peyronie's Disease Bother Score | Week 52 | A responder was defined as a subject who satisfied the following 2 criteria at that visit: a) percent reduction from baseline in curvature deformity was ≥20% and b) reduction from baseline in PDQ Peyronie's disease bother score was ≥1, or had a change from reporting no sexual activity at screening to reporting sexual activity. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change From Baseline in Penile Curvature | Baseline and Week 52 | Efficacy is based on the modified intent-to-treat population (mITT). | percentage of curvature change | MEAN |
| PRIMARY | Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) | Baseline and Week 52 | Efficacy is based on the mITT population. | units on a scale | MEAN |
| SECONDARY | A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease | Week 52 | Efficacy analysis was based on the mITT population. | Number of particpants | NUMBER |
| SECONDARY | Change From Baseline in the Severity of Peyronie's Disease Physical and Psychological Symptoms | Baseline and Week 52 | Efficacy analysis is based on the mITT population. | units on a scale | MEAN |
| SECONDARY | Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF) | Baseline and Week 52 | Efficacy analysis is based on the mITT population. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Penile Plaque Consistency | Baseline and Week 52 | Efficacy analysis is based on the mITT population. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Penile Length | Baseline and Week 52 | Efficacy analysis is based on the mITT population. | centimeters | MEAN |
| SECONDARY | Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4 | Baseline and Week 52 | Efficacy analysis is based on the mITT population. This population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater. | units on a scale | MEAN |
| SECONDARY | Composite Responder Based on Change in Curvature Deformity and Change in Peyronie's Disease Bother Score | Week 52 | Efficacy analysis is based on the mITT population. | Number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change From Baseline in Penile Curvature | AA4500 | -37.6 | Standard Deviation 30.29 | percentage of curvature change | |
| Percentage Change From Baseline in Penile Curvature | Placebo | -21.3 | Standard Deviation 29.89 | percentage of curvature change | |
| Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) | AA4500 | -3.3 | Standard Deviation 3.83 | units on a scale | |
| Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) | Placebo | -2.0 | Standard Deviation 3.53 | units on a scale | |
| A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease | AA4500 | Responder Status-No | 67 | Number of particpants | |
| A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease | Placebo | Responder Status-No | 73 | Number of particpants | |
| A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease | AA4500 | Responder Status-Yes | 131 | Number of particpants | |
| A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease | Placebo | Responder Status-Yes | 30 | Number of particpants | |
| A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease | AA4500 | Responder Status-Missing | 1 | Number of particpants | |
| A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease | Placebo | Responder Status-Missing | 1 | Number of particpants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AA4500 | 277 | |
| Overall Study | STARTED | Placebo | 140 | |
| Overall Study | COMPLETED | AA4500 | 241 | |
| Overall Study | COMPLETED | Placebo | 124 | |
| Overall Study | NOT COMPLETED | AA4500 | 36 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
Source ClinicalTrials.gov
Adverse events104
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 | Penile haematoma | Reproductive system and breast disorders | AA4500 | 171 | 277 | 394 |
| other | Penile haematoma | Reproductive system and breast disorders | Placebo | 19 | 140 | 31 |
| other | Penile pain | Reproductive system and breast disorders | AA4500 | 119 | 277 | 244 |
| other | Penile pain | Reproductive system and breast disorders | Placebo | 11 | 140 | 15 |
| other | Penile swelling | Reproductive system and breast disorders | AA4500 | 114 | 277 | 219 |
| other | Penile swelling | Reproductive system and breast disorders | Placebo | 1 | 140 | 1 |
| other | Injection site pain | General disorders | AA4500 | 70 | 277 | 127 |
| other | Injection site pain | General disorders | Placebo | 5 | 140 | 12 |
| other | Penile haemorrhage | Reproductive system and breast disorders | AA4500 | 60 | 277 | 181 |
| other | Penile haemorrhage | Reproductive system and breast disorders | Placebo | 14 | 140 | 19 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AA4500 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | AA4500 | 248 | 277 |
| Total, other adverse events | Placebo | 55 | 140 |
| Total, serious adverse events | AA4500 | 27 | 277 |
| Total, serious adverse events | Placebo | 7 | 140 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26199168 | DERIVED |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| AA4500 vs Placebo: serious adverse events |
Source 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/NCT01221597
GET https://conductscience.org/api/trials/v1/NCT01221597/results?page=2