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

Sponsored by:	AEterna Zentaris
Information provided by:	AEterna Zentaris
ClinicalTrials.gov Identifier:	NCT00449150

Purpose

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 in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH.

Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.

For this study, study medication (Cetrorelix pamoate or placebo)is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).

Condition	Intervention	Phase
Benign Prostatic Hypertrophy	Drug: Cetrorelix 52 mg week 0, 26, 52 and 78, 26 mg week 2, 28, 54 and 80 Drug: Cetrorelix-Placebo Drug: Placebo-Cetrorelix	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Cetrorelix Pamoate Intermittent IM Dosage Regimens in Patients With Symptomatic BPH: a 1 Year Placebo-Controlled Efficacy Study and Long-Term Safety Assessment

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:

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

Secondary Outcome Measures:

Quality Of Life [ Time Frame: Patient questionnaire ] [ Designated as safety issue: No ]

Estimated Enrollment:	594
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Cetrorelix 52 mg week 0, 26, 52 and 78, 26 mg week 2, 28, 54 and 80 intra muscular-3 doses in 2 weeks each 6 months- duration 80 weeks
2: Experimental	Drug: Cetrorelix-Placebo intra muscular- Cetrorelix 52 mg week 0-26-52 and 78, 26 mg week 2, 54 and 80, placebo week 28
3: Placebo Comparator	Drug: Placebo-Cetrorelix Placebo weeks 0-2-26-28 Cetrorelix 52 mg week 52 and 78, 26 mg week 54 and 80

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449150

Show 68 Study Locations

Sponsors and Collaborators

AEterna Zentaris

Investigators

Principal Investigator:

Dr. Hebert Lepor, MD

New York University School of Medicine

More Information

No publications provided

Responsible Party:	AEterna Zentaris ( Daniel Croteau )
Study ID Numbers:	Z033
Study First Received:	March 15, 2007
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00449150 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by AEterna Zentaris:

Cetrorelix

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hyperplasia
Hypertrophy
Prostatic Diseases
Prostatic Hyperplasia

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

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hypertrophy
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 02, 2009