Clinical Trial: The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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

Detailed Summary:

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 had 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 were recorded.


Sponsor: Endo Pharmaceuticals

Current Primary Outcome:

  • Change From Baseline in Penile Curvature [ Time Frame: Baseline and Week 36 or last observation carried forward (LOCF) ]
    Negative change reflects improvement in penile curvature
  • Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie's Disease Symptom Bother [ Time Frame: Baseline to Week 36 or LOCF ]

    Peyronie's disease Symptom Bother Scale: 0-20 lower numbers reflect 'less symptom bother'; higher numbers reflect 'more symptom bother'

    Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the symptom bother scale.

  • Change From Baseline in PDQ Intercourse Contraint [ Time Frame: Baseline to Week 36 or LOCF ]

    Peyronie's disease intercourse contraint Scale: 0-12 lower numbers reflect 'less intercourse contraint'; higher numbers reflect 'more intercourse constraint'

    Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse constraint scale.

  • Change From Baseline in PDQ Intercourse Discomfort [ Time Frame: Baseline to Week 36 or LOCF ]

    Peyronie's disease intercourse discomfort Scale: 0-15 lower numbers reflect 'less intercourse discomfort'; higher numbers reflect 'more intercourse discomfort'


    Original Primary Outcome: Total scores and change from baseline total scores for each of the four scales of the Peyronie's PRO questionnaire [ Time Frame: Week 36 ]

    Current Secondary Outcome:

    Original Secondary Outcome: Change from baseline and percent change from baseline in penile curvature [ Time Frame: Week 36 ]

    Information By: Endo Pharmaceuticals

    Dates:
    Date Received: September 16, 2008
    Date Started: August 2008
    Date Completion:
    Last Updated: September 7, 2016
    Last Verified: July 2016