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Brief Title † | The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease | ||||
Official Title † | 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 | ||||
Brief Summary | This study will evaluate 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 |
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Detailed Description | A Phase 2b randomized, double-blind, placebo-controlled study of AA4500 in the treatment of subjects with Peyronie's disease. During the screening period, subjects will have a physical examination including body weight and height, vital sign measurements, a 12-lead electrocardiogram (ECG), and clinical laboratory testing. Medical history, prior and concomitant medications, and demographic data will be recorded. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study | ||||
Primary Outcome Measure † | Total scores and change from baseline total scores for each of the four scales of the Peyronie's PRO questionnaire [ Time Frame: Week 36 ] [ Designated as safety issue: No ] | ||||
Secondary Outcome Measure † | Change from baseline and percent change from baseline in penile curvature [ Time Frame: Week 36 ] [ Designated as safety issue: No ] | ||||
Condition † | Peyronie's Disease | ||||
Intervention † | Biological: AA4500 Biological: Placebo |
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Recruitment Information Fields | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 120 | ||||
Start Date † | August 2008 | ||||
Estimated Completion Date | October 2009 | ||||
Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Administrative Information Fields | |||||
NCT ID † | NCT00755222 | ||||
Organization ID | AUX-CC-801 | ||||
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Study Sponsor † | Auxilium Pharmaceuticals | ||||
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Investigators † |
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Information Provided By | Auxilium Pharmaceuticals | ||||
Verification Date | January 2009 | ||||
First Received Date † | September 16, 2008 | ||||
Last Updated Date | January 14, 2009 |