Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH) (AEZS-102-Z041)

AEterna Zentaris

Status and phase

Completed

Phase 3

Conditions

Benign Prostatic Hypertrophy

Treatments

Drug: Cetrorelix Pamoate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00670306

AEZS-102-Z041

Details and patient eligibility

About

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).

Enrollment

528 patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

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