CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 189 enrolled
Drug / intervention
AA4500biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01685437
NCT01685437Phase 3Completed
CompareCT.gov

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

Endo Pharmaceuticals·interventional·Posted Sep 14, 2012·Updated Oct 5, 2017

In Brief

A Phase 3 clinical trial evaluating AA4500 for Peyronie's Disease. Completed, enrolled 189 participants.

Detailed 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeyronie's Disease
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2012
Enrollment StartSep 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.8 years ago

Interventions

AA4500biological

2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles