Trial · NCT00755222

The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease

NCT00755222, Phase 2, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2011-04-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease. Trials, record NCT00755222. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00755222

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease
NCT number: NCT00755222
Status: Completed
Phases: Phase 2
Enrollment: 147 participants, actual
Lead sponsor: Endo USA Inc., a Keenova Therapeutics Company
Conditions: Peyronie's Disease
Interventions: AA4500, Placebo
First posted: 2008-09-18
Last updated: 2017-10-05
Results first posted: 2011-04-26

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Penile Curvature	Baseline and Week 36 or last observation carried forward (LOCF)	Negative change reflects improvement in penile curvature
Primary	Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie's Disease Symptom Bother	Baseline to Week 36 or LOCF	Peyronie's disease Symptom Bother Scale: 0-20 lower numbers reflect 'less symptom bother'; higher numbers reflect 'more symptom bother' Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the symptom bother scale.
Primary	Change From Baseline in PDQ Intercourse Contraint	Baseline to Week 36 or LOCF	Peyronie's disease intercourse contraint Scale: 0-12 lower numbers reflect 'less intercourse contraint'; higher numbers reflect 'more intercourse constraint' Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse constraint scale.
Primary	Change From Baseline in PDQ Intercourse Discomfort	Baseline to Week 36 or LOCF	Peyronie's disease intercourse discomfort Scale: 0-15 lower numbers reflect 'less intercourse discomfort'; higher numbers reflect 'more intercourse discomfort' Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse discomfort scale.
Primary	Change From Baseline in PDQ Penile Pain	Baseline to Week 36 or LOCF	Peyronie's disease penile pain Scale: 0-40 lower numbers reflect 'less penile pain'; higher numbers reflect 'more penile pain' Change from baseline=Week 36 minus baseline. Negative change reflects improvement in the penile pain scale.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change From Baseline in Penile Curvature	Baseline and Week 36 or last observation carried forward (LOCF)	Percent change from baseline	MEAN
PRIMARY	Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie's Disease Symptom Bother	Baseline to Week 36 or LOCF	scores on a scale	MEAN
PRIMARY	Change From Baseline in PDQ Intercourse Contraint	Baseline to Week 36 or LOCF	scores on a scale	MEAN
PRIMARY	Change From Baseline in PDQ Intercourse Discomfort	Baseline to Week 36 or LOCF	scores on a scale	MEAN
PRIMARY	Change From Baseline in PDQ Penile Pain	Baseline to Week 36 or LOCF	scores on a scale	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Penile Curvature	AA4500	-29.7	Standard Deviation 27.16	Percent change from baseline
Change From Baseline in Penile Curvature	Placebo	-11.0	Standard Deviation 30.87	Percent change from baseline
Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie's Disease Symptom Bother	AA4500	-2.6	Standard Deviation 4.63	scores on a scale
Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie's Disease Symptom Bother	Placebo	-0.8	Standard Deviation 3.63	scores on a scale
Change From Baseline in PDQ Intercourse Contraint	AA4500	-1.5	Standard Deviation 3.31	scores on a scale
Change From Baseline in PDQ Intercourse Contraint	Placebo	-0.7	Standard Deviation 3.65	scores on a scale
Change From Baseline in PDQ Intercourse Discomfort	AA4500	-0.8	Standard Deviation 3.46	scores on a scale
Change From Baseline in PDQ Intercourse Discomfort	Placebo	-0.4	Standard Deviation 4.27	scores on a scale
Change From Baseline in PDQ Penile Pain	AA4500	-2.4	Standard Deviation 6.32	scores on a scale
Change From Baseline in PDQ Penile Pain	Placebo	-0.5	Standard Deviation 5.30	scores on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AA4500	111
Overall Study	STARTED	Placebo	36
Overall Study	COMPLETED	AA4500	103
Overall Study	COMPLETED	Placebo	34
Overall Study	NOT COMPLETED	AA4500	8
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events36

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	Injection site bruising	General disorders	AA4500	100	111	236
other	Injection site bruising	General disorders	Placebo	18	36	36
other	Injection site edema	General disorders	AA4500	55	111	87
other	Injection site edema	General disorders	Placebo	0	36	0
other	Injection site pain	General disorders	AA4500	61	111	109
other	Injection site pain	General disorders	Placebo	5	36	7
other	Injection site pruritus	General disorders	AA4500	6	111	8
other	Injection site pruritus	General disorders	Placebo	0	36	0
other	Contusion	Injury, poisoning and procedural complications	AA4500	25	111	42
other	Contusion	Injury, poisoning and procedural complications	Placebo	2	36	4

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse 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	109	111
Total, other adverse events	Placebo	28	36
Total, serious adverse events	AA4500	4	111
Total, serious adverse events	Placebo	1	36

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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00755222

GET https://conductscience.org/api/trials/v1/NCT00755222/events?page=2

API reference For AI assistants