Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)

Completed · Phase 3

Conditions studied: Benign Prostatic Hypertrophy

In brief

Benign Prostatic Hyperplasia (BPH) is the most common hyperplastic disease occuring in human males over the age of 50 which increases in prevalence with age and 40% of males reported moderate or severe urinary symptoms of prostatism by the age of 50 to 80. The purpose of this study is to collect safety and efficacy data for this dosage regimen of cetrorelix pamoate. For this study, study medication (Cetrorelix pamoate) is administered by injection in the buttocks (Intramuscular).

Key facts

Study ID

NCT00670306

Run by

AEterna Zentaris

People needed

528

Starts

2008-03-01

Expected to finish

2009-08-01

Last updated by the study team

2011-04-05

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Benign Prostatic Hyperplasia, based on medical history
• Voiding symptoms
• Uroflow (max) 5-15mL/sec

You may not qualify if…

• Urgent need for prostate surgery
• History of allergic reaction to peptide
• Major organ dysfunction
• Prior surgical treatment of the prostate or bladder
• Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior to trial medication at Week 0 or with α blockers or saw palmetto within the last 6 weeks prior to trial medication at Week 0
• Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy
• History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months

Where it is running

• Medical Affiliated Research Center, Inc. — Huntsville, Alabama, United States
• South Orange County Medical Research Center — Laguna Hills, California, United States
• California Professionnal Research — Newport Beach, California, United States
• Northern California Research — Sacramento, California, United States
• San Diego Uro Research — San Diego, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• West Coast Clinical Research — Tarzana, California, United States
• Genitourinary Surgical Consultants — Denver, Colorado, United States
• Connecticut Clincal Research Center, LLC — Middlebury, Connecticut, United States
• Urological Associates of Bridgeport — Trumbull, Connecticut, United States
• South Florida Medical Research — Aventura, Florida, United States
• Tampa Bay Medical Research — Clearwater, Florida, United States
• University Urologists — Lake Worth, Florida, United States
• Specialists in Urology — Naples, Florida, United States
• Winter Park Urology — Orlando, Florida, United States
• Florida Urology Specialists — Sarasota, Florida, United States
• Mount Vernon Clinical Research, LLC — Sandy Springs, Georgia, United States
• North Idaho Urology — Coeur d'Alene, Idaho, United States
• Northeast Indiana Research, LLC — Fort Wayne, Indiana, United States
• Welborn Clinic — Newburgh, Indiana, United States
• The Iowa Clinic — Des Moines, Iowa, United States
• Four Rivers Clinical Research — Paducah, Kentucky, United States
• Regional Urology, LLC — Shreveport, Louisiana, United States
• Chesapeake Urology Research Associates — Bel Air, Maryland, United States
• Urology Centers of Alabama — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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