Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Benign Prostatic Hypertrophy

In brief

Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement. For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).

Key facts

Study ID

NCT00449150

Run by

AEterna Zentaris

People needed

667

Starts

2007-03-01

Expected to finish

2009-12-01

Last updated by the study team

2018-08-03

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

You may not qualify if…

• Urgent need for prostate surgery or prior surgical treatment of the prostate or bladder
• Major organ dysfunction
• Eczema (atopic dermatitis) treated during the last 6 months
• 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 randomization or with α blockers or saw palmetto within the last 6 weeks prior to randomization
• 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

• Urology Group of Westrn Arkansas — Fort Smith, Arkansas, United States
• South Orange County Medical Research Center — Laguna Hills, California, United States
• California Professionnal Research — Newport Beach, California, United States
• William G. Moseley — San Diego, California, United States
• West Coast Clinical Research — Tarzana, California, United States
• Western Clinical Research, Inc. — Torrance, California, United States
• Urology Research Options — Aurora, Colorado, United States
• Urologic Oncology — Aurora, Colorado, United States
• Genitourinary Surgical Consultants — Denver, Colorado, United States
• Connecticut Clincal Research Center — Middlebury, Connecticut, United States
• South Florida Medical Research — Aventura, Florida, United States
• Tampa Bay Medical Research — Clearwater, Florida, United States
• Atlantic Urological Associates — Daytona Beach, Florida, United States
• Miami VACM — Miami, Florida, United States
• Florida Healthcare Research — Ocala, Florida, United States
• Florida Urologist Specialists — Sarasota, Florida, United States
• Southeastern Research Group — Tallahassee, Florida, United States
• Southwestern Medical Research Institute — Columbus, Georgia, United States
• Northwestern University Feinberg School of Medecine — Chicago, Illinois, United States
• Welborn Clinic — Evansville, Indiana, United States
• Northeast Indiana Research, LLC — Fort Wayne, Indiana, United States
• Kansas City Urology Care — Overland Park, Kansas, United States
• Four Rivers Clinical Research — Paducah, Kentucky, United States
• Myron I. Murdock M.D. LLC — Greenbelt, Maryland, United States
• Medical Affiliated Research Center, Inc. — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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