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NCT01243411 · ClinicalTrials.gov registry record · Phase 3
A Study of AA4500 in Men With Peyronie's Disease
A Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 348
- Enrollment target
NCT01243411: Completed Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT01243411 is a Phase 3 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 348 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01243411, a Phase 3 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 348 participants
- Enrollment target
Study Summary
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.
Primary Outcome
A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.
Interventions
- BIOLOGICAL AA4500
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
What the finished NCT01243411 record still lists
NCT01243411 is an interventional study that assigns participants to a tested intervention. The registered 348 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which AA4500 is the first listed.
NCT01243411 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01243411 about?
NCT01243411 is a clinical study titled "A Study of AA4500 in Men With Peyronie's Disease". 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...
What is the current status of trial NCT01243411?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 348 participants. The study started on 2010-11. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01243411?
The interventions under investigation include: AA4500 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01243411?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01243411's enrollment target sits among peer trials
348 1045th of 2000 higher than 953 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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