A Study of AA4500 in Men With Peyronie's Disease
Public ClinicalTrials.gov record NCT01243411. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. After up to four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 168 (± 7 days) and 252 (± 7 days) (nominal weeks 24 and 36). After the final injection of each treatment cycle, the investigator will model the plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to \<15° after the first, second, or third cycle of injections or if the investigator determines further treatment is not clinically indicated (eg, adverse events; allergic reaction), subsequent treatment cycles will not be administered. Approximately 300 subjects will be enrolled.
Study identification
- NCT ID
- NCT01243411
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 348 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2010 (Type not available)
- Primary completion
- Aug 2012 (Actual)
- Completion
- Aug 2012 (Actual)
- Last update posted
- Oct 5, 2017
2010 – 2012
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Urology Associates Medical Group | Burbank | California | 91505 | — |
| Connecticut Clinical Research Center, LLC | Middlebury | Connecticut | 06762 | — |
| The Urology Center, P.C. | New Haven | Connecticut | 06511 | — |
| South Florida Medical Research | Aventura | Florida | 33180 | — |
| Urology Specialists, S.C. | Chicago | Illinois | 60612 | — |
| Northeast Indiana Research, LLC | Fort Wayne | Indiana | 46825 | — |
| Metropolitan Urology, P.S.C. | Jeffersonville | Indiana | 47130 | — |
| Maimonides Medical Center, Division of Urology | Brooklyn | New York | 11219 | — |
| University Urology Associates | New York | New York | 10016 | — |
| Tristate Urologic Services PSC, Inc./ dba TUG Research | Cincinnati | Ohio | 45212 | — |
| Urologic Consultants of SE PA | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Urology of Virginia-Sentara Medical Group | Norfolk | Virginia | 23502 | — |
| Virginia Urology | Richmond | Virginia | 23235 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01243411, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 5, 2017 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01243411 live on ClinicalTrials.gov.