Status:
COMPLETED
Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
Lead Sponsor:
AEterna Zentaris
Conditions:
Benign Prostatic Hypertrophy
Eligibility:
MALE
50+ years
Phase:
PHASE3
Brief Summary
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 sever...
Eligibility Criteria
Inclusion
- Benign Prostatic Hyperplasia, based on medical history
- Voiding symptoms
- Uroflow (max) 5-15mL/sec
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT00670306
Start Date
March 1 2008
End Date
August 1 2009
Last Update
April 5 2011
Active Locations (69)
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1
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
2
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
3
South Orange County Medical Research Center
Laguna Hills, California, United States, 92653
4
California Professionnal Research
Newport Beach, California, United States, 92660