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

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

This study is ongoing, but not recruiting participants.

First Received: April 22, 2008 Last Updated: January 8, 2009 History of Changes

Sponsored by:	AEterna Zentaris
Information provided by:	AEterna Zentaris
ClinicalTrials.gov Identifier:	NCT00670306

Purpose

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).

Condition	Intervention	Phase
Benign Prostatic Hyperplasia (BPH)	Drug: Cetrorelix Pamoate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Cetrorelix Pamoate (AEZS-102)in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study

Resource links provided by NLM:

Drug Information available for: Cetrorelix Cetrorelix acetate

U.S. FDA Resources

Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:

Incidence of treatment-emergent AEs [ Time Frame: Patient receiving at least one dose of medication ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

BPH Symptoms [ Time Frame: Patient questionnaire ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	March 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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.	Drug: Cetrorelix Pamoate 52 mg week 0, 26 mg week 2,

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670306

Show 69 Study Locations

Sponsors and Collaborators

AEterna Zentaris

More Information

No publications provided

Responsible Party:	AEterna Zentaris ( Daniel Croteau / Medical Manager )
Study ID Numbers:	AEZS-102-Z041
Study First Received:	April 22, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00670306 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AEterna Zentaris:

Cetrorelix
BPH

Study placed in the following topic categories:

Hyperplasia
Prostatic Diseases
Prostatic Hyperplasia
Hormone Antagonists

Hormones, Hormone Substitutes, and Hormone Antagonists
Cetrorelix
Genital Diseases, Male
Hormones

Additional relevant MeSH terms:

Hyperplasia
Pathologic Processes
Prostatic Diseases
Prostatic Hyperplasia
Hormone Antagonists

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cetrorelix
Genital Diseases, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009