Trial · NCT02267460
An Open-label Study to Assess the Safety and Effectiveness of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Treating Men With Peyronie's Disease
NCT02267460, Phase 3, Completed, Endo USA Inc., a Keenova Therapeutics Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-label Study to Assess the Safety and Effectiveness of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Treating Men With Peyronie's Disease. Trials, record NCT02267460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02267460
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label Study to Assess the Safety and Effectiveness of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Treating Men With Peyronie's Disease
- NCT number
- NCT02267460
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Peyronie's Disease
- Interventions
- AA4500, ErecAid® Esteem® Manual Vacuum Therapy System, Investigator Modeling
- First posted
- 2014-10-17
- Last updated
- 2017-11-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent in improvement from baseline in penile curvature | 36 Weeks | measurement of erect penis at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2) |
| Secondary | Change in Peyronies disease bother | 36 Weeks | Questionnaire at Day 168 (follow up 1) and day 252 (follow up 2) |
| Secondary | Change in Peyronies disease physical symptoms | Week 36 | measurement of erect penis at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2) |
| Secondary | Change in Peyronies disease psychological symptoms | 36 Weeks | Questionnaire at Day 168 (follow up 1) and day 252 (follow up 2) |
| Secondary | Change in penile plaque consistency | 36 Weeks | Flaccid penile exam at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2) |
| Secondary | Change in penile length | 36 Weeks | Flaccid penile exam at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2) |
| Secondary | Change in Peyronies disease penile pain | 36 Weeks | examination for pain done on day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2) |
| Secondary | A responder analysis based on subject global assessment | 36 Weeks | Questionnaire at Day 168 (follow up 1) and day 252 (follow up 2) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28974406 | 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 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/NCT02267460
GET https://conductscience.org/api/trials/v1/NCT02267460/registered