Peyronie's Disease Clinical Trial
Official title:
Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease in Studies AUX-CC-802, AUX-CC-803, AUX-CC-804 and AUX-CC-806
This a Phase 4 non-treatment, long-term follow-up study of subjects who received AA4500 in a 12-month double blind placebo-controlled study (AUX CC 803 or AUX-CC-804) or in a 9-month open label study (AUX-CC-802 or AUX-CC-806) sponsored by Auxilium Pharmaceuticals, Inc. After participation in one of the aforementioned studies, subjects will be followed yearly for up to 4 consecutive long-term follow-up visits with at least 6 months between consecutive visits
At each long-term follow-up visit, subjects will be assessed for adverse events relative to
their previous long-term follow-up assessment. Blood samples for the determination of
antibodies to AUX-I and AUX-II and neutralizing antibodies to AUX-I and AUX-II will be
collected at each long-term follow-up visit.
At each long-term follow-up visit, a flaccid penile examination will be performed and a
curvature deformity measurement (with the penis in the erect state) will be recorded.
Subjects will also be asked to complete the Peyronie's Disease Questionnaire (PDQ) and the
International Index of Erectile Function (IIEF) questionnaire. At each visit, medical,
surgical, or other treatments for Peyronie's disease since the last assessment will also be
collected and recorded.
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