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Completed Phase 3 Interventional Results available

Study of AA4500 in the Treatment of Peyronie's Disease

ClinicalTrials.gov ID: NCT01221623

Public ClinicalTrials.gov record NCT01221623. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 12:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for Up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease

Study identification

NCT ID
NCT01221623
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Endo USA Inc., a Keenova Therapeutics Company
Industry
Enrollment
418 participants

Conditions and interventions

Interventions

  • AA4500 Biological
  • Placebo Biological

Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2010
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012
Last update posted
Oct 4, 2017

2010 – 2012

United States locations

U.S. sites
29
U.S. states
18
U.S. cities
29
Facility City State ZIP Site status
Costal Clinical Research, Inc. Mobile Alabama 36608
Alaska Clinical Research Center, LLC Anchorage Alaska 99508
Connect Clinical Research Center (CCRC) Phoenix Arizona 85048
So. Orange County Medical Research Center Laguna Hills California 92653
The Urology Center of Colorado Denver Colorado 80211
Connecticut Clinical Resarch Center, LLC Middlebury Connecticut 06762
South Florida Medical Research Aventura Florida 33180
Winter Park Urology Associates Orlando Florida 32803
Idaho Urologic Institute Meridian Idaho 83642
Northeast Indiana Research, LLC Fort Wayne Indiana 46825
Metropolitan Urology, P.S.C. Jeffersonville Indiana 47130
Kansas City Urology Care, P.A. Research Department Overland Park Kansas 66211
Tulane University Health Sciences Center Dept. of Urology New Orleans Louisiana 70112
Regional Urology L.L.C. Shreveport Louisiana 71106
Chesapeake Urology Research Assoc. Glen Burnie Maryland 21061
Chesapeake Urology Research Assoc., PA Towson Maryland 21204
University of Michigan Ann Arbor Michigan 48109
Cooper Health System Camden New Jersey 08103
AdvanceMed Research Lawrenceville New Jersey 08648
The Capital Region Medical Research Foundation @ the Urological Institute of Northeastern New York Albany New York 12208
Bruce R. Gilbert, MD, PhD, PC Great Neck New York 11021
University Urology Associates New York New York 10016
Michael A. Werner, MD, PC Purchase New York 10577
Universitiy of North Carolina School of Medicine Div. of Urology Chapel Hill North Carolina 27599
Duke University Medical Center Division of Urologic Surgery Durham North Carolina 27710
The Miriam Hospital Providence Rhode Island 02906
Research Across America Carrollton Texas 75010
Urology Clinics of North Texas, PA Dallas Texas 75231
Urology San Antonio Research, PA San Antonio Texas 78229

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01221623, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 4, 2017 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01221623 live on ClinicalTrials.gov.

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