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 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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Percentage Change From Baseline in Penile Curvature [ Time Frame: Baseline and Week 36 ]A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.
- Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) [ Time Frame: Baseline and Week 36 ]Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.
- Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ [ Time Frame: Baseline and Week 36 ]Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.
- Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4 [ Time Frame: Baseline and Week 36 ]Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.
- A Responder Analysis Based on Subject Overall Global Assessment [ Time Frame: Week 36 ]Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicate a responder.
- Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF) [ Time Frame: Baseline and Week 36 ]Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.
- Change From Baseline in Penile Plaque Consistency [ Time Frame: Baseline and Week 36 ]Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline in penile plaque consistency is indicated by a negative number.
- A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score [ Time Frame: Week 36 ]
A composite responder is indicated by
- a percent reduction from baseline in penile curvature greater than or equal to the threshold, and
- a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening.
- Change From Baseline in Penile Length [ Time Frame: Baseline and Week 36 ]A negative value represents a reduction in measurement from baseline.
|Study Start Date:||November 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
collagenase clostridium histolyticum
2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)
Other Name: XIAFLEX
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243411
Show 39 Study Locations
|Study Director:||Gregory J. Kaufman, MD||Auxilium Pharmaceuticals, Inc.|