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

Use our guide to learn which trials are right for you!

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.

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
Avon, Indiana 46123
?
mi
from
Avon, IN
Click here to add this to my saved trials
1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
Anchorage, Alaska 99508
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Aventura, Florida 33180
?
mi
from
Aventura, FL
Click here to add this to my saved trials
216 North Broad Street
Bala-Cynwyd, Pennsylvania 19004
?
mi
from
Bala-Cynwyd, PA
Click here to add this to my saved trials
Burbank, California 91505
?
mi
from
Burbank, CA
Click here to add this to my saved trials
Chestnut Hill, Massachusetts 02467
?
mi
from
Chestnut Hill, MA
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80211
?
mi
from
Denver, CO
Click here to add this to my saved trials
Glen Burnie, Maryland 21061
?
mi
from
Glen Burnie, MD
Click here to add this to my saved trials
Great Neck, New York 11022
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Hackensack, New Jersey 07601
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Jefferson, Indiana 47130
?
mi
from
Jefferson, IN
Click here to add this to my saved trials
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
Lawrenceville, New Jersey 08648
?
mi
from
Lawrenceville, NJ
Click here to add this to my saved trials
Meridian, Idaho 83642
?
mi
from
Meridian, ID
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Overland Park, Kansas 66211
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
Purchase, New York 10577
?
mi
from
Purchase, NY
Click here to add this to my saved trials
Raleigh, North Carolina 27607
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Richmond, Virginia 23235
?
mi
from
Richmond, VA
Click here to add this to my saved trials
San Diego, California 92120
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Towson, MD
Click here to add this to my saved trials
Virginia Beach, Virginia 23462
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
Wellington, Florida 33449
?
mi
from
Wellington, FL
Click here to add this to my saved trials
Winfield, Illinois 60190
?
mi
from
Winfield, IL
Click here to add this to my saved trials