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

Sponsored by:	AEterna Zentaris
Information provided by:	AEterna Zentaris
ClinicalTrials.gov Identifier:	NCT00663858

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 Drug: placebo	Phase III

Drug Information available for: Cetrorelix Cetrorelix acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-Blind Placebo-Controlled Efficacy Study

Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:

BPH symptoms (IPSS questionnaire) [ Time Frame: Week 26, 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life (questionnaire) [ Time Frame: Week 26, 52 ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	March 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: cetrorelix intramuscular: 52 mg in week 0, 26, 52 and 78; 26 mg in week 2, 28, 54 and 80
B: Experimental	Drug: cetrorelix intramuscular: 52 mg in week 0, 52 and 78; 26 mg in week 2, 54 and 80; placebo in week 26 and 28
C: Placebo Comparator open-label follow-up (week 52+): cetrorelix	Drug: placebo intramuscular placebo in week 0, 2, 26, 28 (open-label follow-up: cetrorelix 52 mg in week 52 and 78; 26 mg in 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: NCT00663858

Show 57 Study Locations

Sponsors and Collaborators

AEterna Zentaris

Investigators

Study Chair:

Frans MJ Debruyne, M.D.

Andros Mannenkliniek, Arnhem, The Netherlands

More Information

Responsible Party:	AEterna Zentaris ( Markus Mueller, MD, Medical Manager )
Study ID Numbers:	AEZS-102-036
Study First Received:	April 17, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00663858
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Romania: State Institute for Drug Control; Belarus: Ministry of Health; Czech Republic: State Institute for Drug Control; Bulgaria: Ministry of Health; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; France: Ministry of Health; Macedonia: Ethics Committee; Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hyperplasia
Hypertrophy
Prostatic Diseases

Prostatic Hyperplasia
Cetrorelix
Genital Diseases, Male

Additional relevant MeSH terms:

Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009