Status:
TERMINATED
Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
Lead Sponsor:
AEterna Zentaris
Conditions:
Benign Prostatic Hypertrophy
Eligibility:
MALE
50+ years
Phase:
PHASE3
Brief Summary
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 i...
Detailed Description
The objectives of the study are to develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in BPH-related signs and symptoms. Patients will ...
Eligibility Criteria
Inclusion
- Benign Prostatic Hyperplasia, based on medical history
- Voiding symptoms
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
667 Patients enrolled
Trial Details
Trial ID
NCT00449150
Start Date
March 1 2007
End Date
December 1 2009
Last Update
August 3 2018
Active Locations (68)
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1
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
2
Urology Group of Westrn Arkansas
Fort Smith, Arkansas, United States, 72901
3
South Orange County Medical Research Center
Laguna Hills, California, United States, 92653
4
California Professionnal Research
Newport Beach, California, United States, 92660