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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Treatment | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subjects Previously Treated with AA4500 | Drug | no treatment to be administered - observational only |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the long-term safety of AA4500 in adult men with Peyronies disease | 5 years post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500 | 5 years post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the long-term immunogenicity profile of AA4500 in adult men with Peyronies disease | 5 years post treatment |
Inclusion Criteria:
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).
Be able and willing to comply with the follow-up assessments outlined in the protocol, as determined by the investigator.
Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
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Exclusion Criteria:
None
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Up to 750 subjects who received 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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Clinical Research Center, LLC | Anchorage | Alaska | 99503 | United States | ||
| Urology Assoc Medical Group |
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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.
| Burbank |
| California |
| 91505 |
| United States |
| South Orange County Med Research Center | Laguna Hills | California | 92653 | United States |
| San Diego Sexual Medicine | San Diego | California | 92120 | United States |
| The Urology Center of Colorado | Denver | Colorado | 80211 | United States |
| South Florida Medical Research | Aventura | Florida | 33180 | United States |
| Florida Urology Associates | Orlando | Florida | 32803 | United States |
| Georgis Patsias, M.D., PA | Wellington | Florida | 33449 | United States |
| Idaho Urologic Institute | Meridian | Idaho | 83642 | United States |
| Uropartners, LLC | Chicago | Illinois | 60612 | United States |
| Dupage Medical Group | Winfield | Illinois | 60190 | United States |
| Urology of Indiana LLC | Avon | Indiana | 46123 | United States |
| Metropolitan Urology P.S.C | Jefferson | Indiana | 47130 | United States |
| Kansas City Urology Care, PA | Overland Park | Kansas | 66211 | United States |
| Chesapeake Urology Research Associates | Glen Burnie | Maryland | 21061 | United States |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | United States |
| Men's Health Boston | Chestnut Hill | Massachusetts | 02467 | United States |
| Center for Male Reproductive Medicine | Hackensack | New Jersey | 07601 | United States |
| Premier Urology Assoc LLC dba AdvanceMed Research | Lawrenceville | New Jersey | 08648 | United States |
| Community Care Physicians, PC | Albany | New York | 12208 | United States |
| Bruce R. Gilbert, MD, PhD, PC | Great Neck | New York | 11021 | United States |
| Manhattan Medical Research Practice PLLC | New York | New York | 10016 | United States |
| Michael A. Werner, MD PC | Purchase | New York | 10577 | United States |
| Associated Urologists of North Carolina | Raleigh | North Carolina | 27612 | United States |
| Tristate Urologic Services dba TUG Research | Cincinnati | Ohio | 45212 | United States |
| Urologic Consultants of SE PA | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Urology Clinics of North Texas, PA | Dallas | Texas | 75231 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| Virginia Urology | Richmond | Virginia | 23235 | United States |
| Urology of Virginia, PLLC | Virginia Beach | Virginia | 23462 | United States |
| ID | Term |
|---|---|
| D010411 | Penile Induration |
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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