At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 147 enrolled
Drug / intervention
AA4500 +1 morebiological
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.
A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effectiveness of AA4500 Administered Two Times a Week for Up to Three Treatment Cycles (2 x 3) in Subjects With Peyronie's Disease
In Brief
A Phase 2 clinical trial evaluating AA4500 and Placebo for Peyronie's Disease. Completed, enrolled 147 participants across 12 sites.
Detailed Summary
This study evaluated the safety and effectiveness of AA4500 in improving the impact of Peyronie's disease on quality of life and improving penile curvature in men with Peyronie's disease
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeyronie's Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedSep 2008
Primary CompletionDec 2009
TodayJul 2026
First PostedSep 18, 2008
Enrollment StartAug 1, 2008
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.8 years ago
Interventions
AA4500biological
2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series was separated by 6 weeks.
Placebobiological
2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series is separated by 6 weeks.