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Suspended Phase 4 Interventional

The Plenaxis® Experience Study

ClinicalTrials.gov ID: NCT00103623

Public ClinicalTrials.gov record NCT00103623. 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 Oct 25, 2026, 5:55 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

Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Praecis is currently conducting a 2000 patient Experience Study; this is a Phase IV commitment postmarketing safety study in the Food and Drug Administration (FDA) indicated population of patients receiving Plenaxis®. The purpose of the study is to estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis® and to determine whether the hazard rate changes over time.

Study identification

NCT ID
NCT00103623
Recruitment status
Suspended
Study type
Interventional
Phase
Phase 4
Lead sponsor
PRAECIS Pharmaceuticals Inc.
Industry
Enrollment
2,000 participants

Conditions and interventions

Interventions

Drug

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
Jun 2004 (Type not available)
Primary completion
Not listed
Completion
Dec 2008 (Type not available)
Last update posted
Sep 19, 2006

2004 – 2008

United States locations

U.S. sites
60
U.S. states
24
U.S. cities
57
Facility City State ZIP Site status
Millenium Therapeutics & Research - Urology Practice Birmingham Alabama 35205 —
Valley Urologic Associates Goodyear Arizona 85338 —
Foundation for Cancer Research and Education Phoenix Arizona 85013 —
Arizona Urologic Specialists Tucson Arizona 85712 —
Alfred Sidhom, MD, FACS, PC Anaheim California 92801 —
Dr. Chris Threatt Atherton California 94027 —
Hematology-Oncology Group of Fresno Fresno California 93720 —
South Orange County Medical Research Center Laguna Woods California 92653 —
Atlantic Urological Medical Group Long Beach California 90806 —
Paul Neustein, MD. INC Poway California 92064 —
San Diego Urology San Diego California 91942 —
Sherman Oaks Urological Medical Group, Inc. Sherman Oaks California 91403 —
Urology Associates PC Denver Colorado 80210 —
Urologic Associates Fort Meyers Florida 33919 —
Southwest Florida Urologic Associates Fort Myers Florida 33907 —
University of Florida Shands Jacksonville Jacksonville Florida 32209 —
UroSearch Ocala Florida 34470 —
Urology Associates of Ocala, P.A. Ocala Florida 34474 —
South Florida Urology Center Inc Pembroke Pines Florida 33028 —
South Florida Urology Center, Inc. Pembroke Pines Florida 33028 —
Uro-Medix, Inc Sunrise Florida 33351 —
Osvaldo F. Padron MD, FACS Tampa Florida 33614 —
Urological Surgical Services Tavares Florida 32778 —
Osler Medical West Melbourne Florida 32901 —
Urology Associates, P.C. Marietta Georgia 30060 —
Praire Medical Associates, LTD Chicago Illinois 60616 —
Midwest Prostate Urology Health Center Chicago Illinois 60640 —
Urology of Indiana Indianapolis Indiana 46254 —
Unity HealthCare DBA Lafayette Clinic of Urology Lafayette Indiana 47905 —
Heartland Oncology and Hematology Council Bluffs Iowa 51503 —
Private Practice Emporia Kansas 66801 —
KUMC Department of Urology Kansas City Kansas 66160 —
Tri-County Urology Milford Massachusetts 01757 —
Bay State Clinical Trials Inc Watertown Massachusetts 02472 —
Lakeside Urology Saint Joseph Michigan 49085 —
Tewodros Fresseha MD PC Southfield Michigan 48075 —
Midwest Urology Independence Missouri 64055 —
Kansas City Urology Care Kansas City Missouri 64131 —
Quality Clinical Research, LLC Omaha Nebraska 68114 —
Sheldon j. Freedman, MD Ltd Las Vegas Nevada 89109 —
Essex-Hudson Urology Bloomfield New Jersey 07003 —
Hunterdon Urological Associates, PA Flemington New Jersey 08822 —
Northwest Urology Associates Morristown New Jersey 07960 —
Roseland Surgical Suite Roseland New Jersey 07068 —
Urology Healthcare Associates/Rancocas Medical Center Willingboro New Jersey 08046 —
Staten Island Urological Research, PC Staten Island New York 10304 —
University of North Carolina, Chapel Hill Chapel Hill North Carolina 27599 —
American Health Research Charlotte North Carolina 28207 —
Northeast Urology Research Concord North Carolina 28025 —
Washington Urological Associates Washington North Carolina 27889 —
Columbus Urology Research Columbus Ohio 43214 —
Parkhurst Research Organization Bethany Oklahoma 73008 —
Bryn Mawr Urology Devon Pennsylvania 19333 —
Dr. Peter Sinaiko Langhorne Pennsylvania 19047 —
Urology and Urological Oncology Philadelphia Pennsylvania 19141 —
Triangle Urological Group Pittsburgh Pennsylvania 15212 —
Carolina Urologic Research Center Myrtle Beach South Carolina 29572 —
Dr. Greg Echt Irving Texas 75062 —
North West Prostate Institute Seattle Washington 98133 —
Roger D. Fincher, MD Spokane Washington 99202 —

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00103623, 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 Sep 19, 2006 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00103623 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →