Trial · NCT01685437
A Phase 3, Open-label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease
NCT01685437, Phase 3, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2015-04-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3, Open-label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease. Trials, record NCT01685437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01685437
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3, Open-label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease
- NCT number
- NCT01685437
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 189 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Peyronie's Disease
- Interventions
- AA4500
- First posted
- 2012-09-14
- 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 36 | 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 36 | 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 | Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ | Baseline and Week 36 | 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 From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4 | Baseline and Week 36 | 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 | A Responder Analysis Based on Subject Overall Global Assessment | Week 36 | Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicate a responder. |
| Secondary | Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF) | Baseline and Week 36 | 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 36 | Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline in penile plaque consistency is indicated by a negative number. |
| Secondary | A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score | Week 36 | A composite responder is indicated by * a percent reduction from baseline in penile curvature greater than or equal to the threshold, and * a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening. |
| Secondary | Change From Baseline in Penile Length | Baseline and Week 36 | A negative value represents a reduction in measurement from baseline. |
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 36 | Efficacy is based on modified intent-to-treat (mITT) population. | 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 36 | Efficacy is based on the mITT population. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ | Baseline and Week 36 | Efficacy is based on the mITT population. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4 | Baseline and Week 36 | Efficacy 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 | A Responder Analysis Based on Subject Overall Global Assessment | Week 36 | Efficacy is based on the mITT population. | participants | NUMBER |
| SECONDARY | Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF) | Baseline and Week 36 | Efficacy is based on the mITT population. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Penile Plaque Consistency | Baseline and Week 36 | Efficacy is based on the mITT population. | units on a scale | MEAN |
| SECONDARY | A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score | Week 36 | Composite responder analysis is based on the intent-to-treat (ITT) population. | participants | NUMBER |
| SECONDARY | Change From Baseline in Penile Length | Baseline and Week 36 | Efficacy is based on the mITT population. | centimeters | MEAN |
Source ClinicalTrials.gov
Results by group12
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 | -36.3 | Standard Deviation 30.72 | percentage of curvature change | |
| Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) | AA4500 | -2.4 | Standard Deviation 3.34 | units on a scale | |
| Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ | AA4500 | -2.9 | Standard Deviation 4.76 | units on a scale | |
| Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4 | AA4500 | -4.5 | Standard Deviation 4.75 | units on a scale | |
| A Responder Analysis Based on Subject Overall Global Assessment | AA4500 | Responder Status - No | 32 | participants | |
| A Responder Analysis Based on Subject Overall Global Assessment | AA4500 | Responder Status - Yes | 94 | participants | |
| Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF) | AA4500 | 0.7 | Standard Deviation 2.13 | units on a scale | |
| Change From Baseline in Penile Plaque Consistency | AA4500 | -0.4 | Standard Deviation 0.81 | units on a scale | |
| A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score | AA4500 | No | 85 | participants | |
| A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score | AA4500 | Yes | 83 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AA4500 | 189 | |
| Overall Study | COMPLETED | AA4500 | 158 | |
| Overall Study | NOT COMPLETED | AA4500 | 31 |
Source ClinicalTrials.gov
Adverse events13
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 | 114 | 189 | 271 |
| other | Penile pain | Reproductive system and breast disorders | AA4500 | 64 | 189 | 121 |
| other | Penile swelling | Reproductive system and breast disorders | AA4500 | 57 | 189 | 99 |
| other | Penile oedema | Reproductive system and breast disorders | AA4500 | 46 | 189 | 91 |
| other | Penile haemorrhage | Reproductive system and breast disorders | AA4500 | 39 | 189 | 73 |
| other | Injection site haematoma | General disorders | AA4500 | 35 | 189 | 66 |
| other | Injection site pain | General disorders | AA4500 | 32 | 189 | 50 |
| other | Injection site haemorrhage | General disorders | AA4500 | 21 | 189 | 56 |
| other | Injection site swelling | General disorders | AA4500 | 20 | 189 | 27 |
| other | Contusion | Injury, poisoning and procedural complications | AA4500 | 17 | 189 | 20 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AA4500 | ||
| Total, other adverse events | AA4500 | 178 | 189 |
| Total, serious adverse events | AA4500 | 3 | 189 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01685437
GET https://conductscience.org/api/trials/v1/NCT01685437/registered