Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease
Status: | Completed |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - 90 |
Updated: | 6/22/2018 |
Start Date: | November 2014 |
End Date: | April 9, 2018 |
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
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.
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.
Inclusion Criteria:
1. Have received at least one injection of AA4500 and completed at least the first or
last follow-up visit in one of the Auxilium-sponsored studies (AUX CC-802, AUX-CC-803,
AUX-CC-804, or AUX-CC-806).
2. Be able and willing to comply with the follow-up assessments outlined in the protocol,
as determined by the investigator.
3. Voluntarily sign and date an informed consent agreement approved by the Institutional
Review Board/Independent Ethics Committee (IRB/IEC).
Exclusion Criteria:
We found this trial at
30
sites
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