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Study of AA4500 in the Treatment of Peyronie's Disease
NCT01221623 · View on ClinicalTrials.gov ↗
Study Summary
This study is a Phase 3, double-blind, randomized, placebo-controlled study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Approximately 300 (200 AA4500 and 100 placebo) men will be randomized. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. Before dosing, subjects will be stratified by degree of penile curvature (ie, 30º to 60º or 61º to 90º) and then randomized into two treatment groups to receive in a 2:1 ratio either AA4500 0.58 mg or placebo. In this study, qualified subjects may receive up to four treatment cycles; each cycle will be separated by a period of 42 days (± 5 days). During each treatment cycle, subjects will receive two injections of study drug with at least 24 hours but not more than 72 hours between injections. After the final injection of each treatment cycle, the investigator or qualified designee will model the penile plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to \< 15 degrees 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. Following the maximum of four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 169 (± 7 days), 232 (± 7 days), 295 (± 7 days), 365 (± 7 days) (nominal weeks 24, 33, 42 and 52). Subjects randomized to placebo may receive open-label AA4500 treatment after completing this study as part of another protocol.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL AA4500
Study Locations (20)
Florida
- South Florida Medical Research — Aventura
- Winter Park Urology Associates — Orlando
Indiana
- Northeast Indiana Research, LLC — Fort Wayne
- Metropolitan Urology, P.S.C. — Jeffersonville
Louisiana
- Tulane University Health Sciences Center Dept. of Urology — New Orleans
- Regional Urology L.L.C. — Shreveport
Maryland
- Chesapeake Urology Research Assoc. — Glen Burnie
- Chesapeake Urology Research Assoc., PA — Towson
New Jersey
- Cooper Health System — Camden
- AdvanceMed Research — Lawrenceville
Alabama
- Costal Clinical Research, Inc. — Mobile
Alaska
- Alaska Clinical Research Center, LLC — Anchorage
Arizona
- Connect Clinical Research Center (CCRC) — Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 418 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01221623
The ClinicalTrials.gov registry entry for NCT01221623 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 418 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Peyronie's Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01221623 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Indiana, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01221623 about?
NCT01221623 is a clinical study titled "Study of AA4500 in the Treatment of Peyronie's Disease". This study is a Phase 3, double-blind, randomized, placebo-controlled study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Approximately 300 (200 AA4500 and 100 placebo) men will be randomized. Subjects will be screened for study eligibility within 21 days before t...
What is the current status of trial NCT01221623?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 418 participants. The study started on 2010-10. Estimated completion is 2012-03.
What conditions does trial NCT01221623 study?
This clinical trial studies the following conditions: Peyronie's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01221623?
The interventions under investigation include: Placebo (BIOLOGICAL), AA4500 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01221623?
This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01221623 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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