Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
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).
Inclusion Criteria:

 -  Benign Prostatic Hyperplasia, based on medical history

 -  Voiding symptoms

 -  Uroflow (max) 5-15mL/sec

 Exclusion Criteria:

 -  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