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Clinical trialNCT01685437CompletedPhase 3Interventional

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

SponsorEndo USA Inc., a Keenova Therapeutics CompanyEnrollment189Peyronie's Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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. Enrollment will include all subjects who meet the eligibility criteria and who received placebo and completed one of the Auxilium-sponsored studies AUX-CC-803 or AUX-CC-804.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

No facility list is in our current data snapshot for this study. The registry record on ClinicalTrials.gov ↗ carries any published locations. Why? →

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

AA4500
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2012
Primary completion
31 Dec 2013
Completion
31 Dec 2013
Last update posted
5 Oct 2017
Registered enrollment
189
Registry id
NCT01685437

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.