Status:
COMPLETED
Cetrorelix Pamoate 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...
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 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00663858
Start Date
March 1 2008
End Date
January 1 2010
Last Update
January 17 2011
Active Locations (55)
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1
19th Central Regional Policlinic, Urology department
Minsk, Belarus, 220 023
2
4th City Hospital
Minsk, Belarus, 220 036
3
Minsk Regional Clinical Hospital, Clinic of Urology
Minsk, Belarus, 223 052
4
University multiprofil Hospital of Active Treatment "Sveti Georgi", Urology Department
Plovdiv, Bulgaria, 4000