Trial · NCT01430169
Pharmacokinetics of a Single Treatment Cycle of AA4500 0.58 mg in Men With Peyronie's Disease
NCT01430169, Phase 2, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2015-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacokinetics of a Single Treatment Cycle of AA4500 0.58 mg in Men With Peyronie's Disease. Trials, record NCT01430169. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01430169
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics of a Single Treatment Cycle of AA4500 0.58 mg in Men With Peyronie's Disease
- NCT number
- NCT01430169
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Peyronie's Disease
- Interventions
- AA4500
- First posted
- 2011-09-08
- Last updated
- 2017-10-05
- Results first posted
- 2015-05-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | AUX-I Cmax After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Maximum AUX-I (clostridial type I collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA). |
| Primary | AUX-II Cmax After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Maximum AUX-II (clostridium Type II collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA). |
| Primary | AUX-I AUC0-tlast After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA). |
| Primary | AUX-II AUC0-tlast After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA). |
| Primary | AUX-I Tmax After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Time to maximum AUX-I enzyme concentration. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA). |
| Primary | AUX-II Tmax After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Time to maximum AUX-II enzyme concentration. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA). |
| Primary | AUX-I Cmax After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Maximum AUX-I enzyme concentration from zero to 24 hours after Injection 2.AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA). |
| Primary | AUX-II Cmax After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Maximum AUX-II enzyme concentration from zero to 24 hours after Injection 2. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA). |
| Primary | AUX-I AUC0-tlast After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA). |
| Primary | AUX-II AUC0-tlast After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | AUX-I Cmax After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference) | ng/mL | MEAN |
| PRIMARY | AUX-II Cmax After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Pharmacokinetic (PK) population (N=19). | ng/mL | MEAN |
| PRIMARY | AUX-I AUC0-tlast After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Pharmacokinetic population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference) | ng*h/mL | MEAN |
| PRIMARY | AUX-II AUC0-tlast After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Pharmacokinetic (PK) population (N=19) | ng*h/mL | MEAN |
| PRIMARY | AUX-I Tmax After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Pharmacokinetic (PK) population (N=19). For 3 subjects Tmax was considered missing if concentration was BLQ for all time points at that injection and 2 subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference) | hours | MEAN |
| PRIMARY | AUX-II Tmax After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Pharmacokinetic (PK) population (N=19) One subject was excluded from AUX-II PK analyses due to insufficient quantities of plasma for bioanalysis. Of the 38 AUX-II profiles, 23 had no quantifiable plasma concentrations at any time point through 24 hours post injection. | hours | MEAN |
| PRIMARY | AUX-I Cmax After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference) | ng/mL | MEAN |
| PRIMARY | AUX-II Cmax After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Pharmacokinetic (PK) population (N=19) | ng/mL | MEAN |
| PRIMARY | AUX-I AUC0-tlast After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference) | ng*h/mL | MEAN |
| PRIMARY | AUX-II AUC0-tlast After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Pharmacokinetic (PK) population (N=19) | ng*h/mL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| AUX-I Cmax After Injection 1 | AA4500 | 12.6 | Standard Deviation 8.3 | ng/mL | |
| AUX-II Cmax After Injection 1 | AA4500 | 15.1 | Standard Deviation 19.2 | ng/mL | |
| AUX-I AUC0-tlast After Injection 1 | AA4500 | 3.1 | Standard Deviation 2.1 | ng*h/mL | |
| AUX-II AUC0-tlast After Injection 1 | AA4500 | 2.2 | Standard Deviation 3.9 | ng*h/mL | |
| AUX-I Tmax After Injection 1 | AA4500 | 0.15 | Standard Deviation 0.09 | hours | |
| AUX-II Tmax After Injection 1 | AA4500 | 0.16 | Standard Deviation 0.08 | hours | |
| AUX-I Cmax After Injection 2 | AA4500 | 12.2 | Standard Deviation 9.1 | ng/mL | |
| AUX-II Cmax After Injection 2 | AA4500 | 16.1 | Standard Deviation 23.2 | ng/mL | |
| AUX-I AUC0-tlast After Injection 2 | AA4500 | 2.4 | Standard Deviation 2.3 | ng*h/mL | |
| AUX-II AUC0-tlast After Injection 2 | AA4500 | 2.3 | Standard Deviation 4.1 | ng*h/mL |
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 | 20 | |
| Overall Study | COMPLETED | AA4500 | 20 | |
| Overall Study | NOT COMPLETED | AA4500 | 0 |
Source ClinicalTrials.gov
Adverse 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 | Penile haemorrhage | Reproductive system and breast disorders | AA4500 | 19 | 20 | 23 |
| other | Injection site pain | General disorders | AA4500 | 15 | 20 | 15 |
| other | Procedural pain | Injury, poisoning and procedural complications | AA4500 | 9 | 20 | 10 |
| other | Penile swelling | Reproductive system and breast disorders | AA4500 | 6 | 20 | 6 |
| other | Painful erection | Reproductive system and breast disorders | AA4500 | 4 | 20 | 4 |
| other | Penile pain | Reproductive system and breast disorders | AA4500 | 4 | 20 | 5 |
| other | Post procedural discomfort | Injury, poisoning and procedural complications | AA4500 | 2 | 20 | 2 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | AA4500 | 1 | 20 | 1 |
| other | Dizziness | Nervous system disorders | AA4500 | 1 | 20 | 1 |
| other | Fall | Injury, poisoning and procedural complications | AA4500 | 1 | 20 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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 | 20 | 20 |
| Total, serious adverse events | AA4500 | 0 | 20 |
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.
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GET https://conductscience.org/api/trials/v1/NCT01430169/registered