Safety and Efficacy of AA4500 in men with Peyronie’s Disease

• Research type

  Research Study

• Full title

  A phase 3b, open-label pilot study to evaluate the safety and effectiveness of up to four treatment cycles of AA4500 in combination with the ErecAid® Esteem® Manual Vacuum Therapy System in men with Peyronie’s disease.

• IRAS ID

  146385

• Contact name

  David Ralph

• Contact email

  dralph@andrology.co.uk

• Sponsor organisation

  Auxilium Pharmaceuticals Inc,

• Eudract number

  2013-005384-66

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The objectives of this study are to assess the safety and effectiveness of AA4500 (Collagenase Clostridium Histolyticum)in combination with the ErecAid® Esteem® Manual Vacuum Therapy System in improving curvature deformity in men with Peyronie’s disease. This is a single center pilot study where up to 30 patients will be enrolled to receive up to 4 treatment cycles of of AA4500. Success of the treatment will be defined as the percent improvement from baseline in penile curvature.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  14/LO/0200

• Date of REC Opinion

  8 Apr 2014

• REC opinion

  Further Information Favourable Opinion