Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH) - Tabular View

Tracking Information
First Received Date ^ICMJE	April 22, 2008
Last Updated Date	January 8, 2009
Start Date ^ICMJE	March 2008
Estimated Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 8, 2009)	Incidence of treatment-emergent AEs [ Time Frame: Patient receiving at least one dose of medication ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: April 29, 2008)	Collection of safety data [ Time Frame: Patient receiving at least one dose of medication ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00670306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 29, 2008)	BPH Symptoms [ Time Frame: Patient questionnaire ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
Official Title ^ICMJE	Cetrorelix Pamoate (AEZS-102)in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study
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 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).
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Benign Prostatic Hyperplasia (BPH)
Intervention ^ICMJE	Drug: Cetrorelix Pamoate
Study Arms / Comparison Groups	Experimental: Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	500
Estimated Completion Date	May 2009
Estimated Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00670306
Responsible Party	Daniel Croteau / Medical Manager, AEterna Zentaris
Study ID Numbers ^ICMJE	AEZS-102-Z041
Study Sponsor ^ICMJE	AEterna Zentaris
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	AEterna Zentaris
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP