Phase 3 study of AA500 in men with Peyronie's disease (V2:08Sep10)
Research type
Research Study
Full 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 (2x4) in men with Peyronie's disease
IRAS ID
69377
Contact name
David Ralph
Sponsor organisation
Auxilium UK Limited
Eudract number
2010-022921-13
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
This study will investigate how effective and safe AA4500 is in the treatment of Peyronie's disease.Peyronie's disease is a connective tissue disorder involving the growth of fibrous plaques (scar tissue) in the soft tissue of the penis causing an abnormal curvature of the penis (easily seen during an erection).The fibrosing process occurs in the tunica albuginea (lining that surrounds the tissue of the penis that's responsible to create and maintain an erection).The benefit for research participants will be a potential improvement in their Peyronie's disease symptoms, possibly preventing surgical intervention and helping to improve the treatment of other men with Peyronie's disease in the future.Once eligibility has been confirmed (screening visit), participants may receive up to 4 cycles of treatment (3 to 4 visits as part of each cycle) and 2 follow up visits (for additional safety and efficacy assessments) over a period of 10 months.The study will recruit 250 men, aged 18 years or older, at approximately 30 research centres across Europe, New Zealand and the United States.The study is being funded by the Sponsor, Auxilium UK Limited (legal entity).
REC name
London - Fulham Research Ethics Committee
REC reference
10/H0711/97
Date of REC Opinion
2 Mar 2011
REC opinion
Further Information Favourable Opinion