Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)

Benign Prostatic Hypertrophy Clinical Trial

Official title:

Cetrorelix Pamoate Intermittent Intramuscular (IM) Dosage Regimens in Patients With Symptomatic BPH: a 1 Year Placebo-controlled Efficacy Study and Long-term Safety Assessment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00449150
• Other study ID #: Z033
• Status: Terminated
• Phase: Phase 3
• Start date: March 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2011
• Source: AEterna Zentaris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

The objectives of the study are to develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in BPH-related signs and symptoms.

Patients will enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS).

Patients will then be allocated to study drug in a double-blind, randomized, double-dummy, placebo-controlled fashion.

Patients will be administered an IM injection of study drug at Week 0, 2, 26 and 28 and will be followed up to Week 52.

Then, in an open label fashion, patients will be administered an IM injection of study drug at Week 52, 54, 78 and 80 and will be followed up to Week 90.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 667
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 a reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior randomization or with a 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

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy
• Hypertrophy
• Prostatic Hyperplasia

Intervention

Drug:
• Cetrorelix 78 mg + 78 mg

• Cetrorelix 78 mg + 52 mg

• Placebo

Locations

Country	Name	City	State
Bulgaria	National Oncological Hospital	Sofia
Canada	The Male / FemaleHealth and Research Center	Barrie	Ontario
Canada	Urology South Shore Research	Greenfield Park	Quebec
Canada	Southern Interior Medical Research Inc.	Kelowna	British Columbia
Canada	Centre for Advanced Urological Research	Kingston	Ontario
Canada	Urologic Associates, Urologic Medical Research	Kitchener	Ontario
Canada	CHUM, Hopital St-Luc	Montréal	Quebec
Canada	Canada Place Building	North Bay	Ontario
Canada	The Fe/Male Health Centers	Oakville	Ontario
Canada	Dynamik Research	Pointe Claire	Quebec
Canada	CRCEO	Québec	Quebec
Canada	Andreou Research Inc.	Surrey	British Columbia
Canada	The Male Health Center	Toronto	Ontario
Canada	University Health Network Princess Margaret Hospital	Toronto	Ontario
Canada	Can-Med Clinical Reserach Inc.	Victoria	British Columbia
Germany	ClinPharm International GmbH Prufzentrum Berlin	Berlin
Germany	ClinPharm International GmbH Prufzentrum Bochum	Bochum
Germany	ClinPharm International GmbH Prufzentrum Dresden	Dresden
Germany	ClinPharm International GmbH Prufzentrum Frankfurt	Frankfurt
Germany	ClinPharm International GmbH Prufzentrum Gorlitz	Gorlitz
Germany	ClinPharm International GmbH Prufzentrum Leipzig	Leipzig
Germany	ClinPharm International GmbH Prufzentrum Magdeburg	Magdeburg
United States	Urology Group Of New Mexico	Albuquerque	New Mexico
United States	Urologic Oncology	Aurora	Colorado
United States	Urology Research Options	Aurora	Colorado
United States	South Florida Medical Research	Aventura	Florida
United States	Medical & Clinical Research Associates	Bay Shore	New York
United States	Parkhurst Research Oganization Inc.	Bethany	Oklahoma
United States	Northwestern University Feinberg School of Medecine	Chicago	Illinois
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Southwestern Medical Research Institute	Columbus	Georgia
United States	Northeast Urology Research	Concord	North Carolina
United States	Corpus Christi Urology Group	Corpus Christi	Texas
United States	University of Texas Southwestern Medical Center, Department of Urology	Dallas	Texas
United States	Urology Clinics of North Texas	Dallas	Texas
United States	Atlantic Urological Associates	Daytona Beach	Florida
United States	Genitourinary Surgical Consultants	Denver	Colorado
United States	Welborn Clinic	Evansville	Indiana
United States	Urology Group of Westrn Arkansas	Fort Smith	Arkansas
United States	Northeast Indiana Research, LLC	Fort Wayne	Indiana
United States	Urological Surgeons of Long Island, Clinical Research Division	Garden City	New York
United States	Myron I. Murdock M.D. LLC	Greenbelt	Maryland
United States	Institute and the Texas Prostate Center	Houston	Texas
United States	Medical Affiliated Research Center, Inc.	Huntsville	Alabama
United States	South Orange County Medical Research Center	Laguna Hills	California
United States	Miami VACM	Miami	Florida
United States	Connecticut Clincal Research Center	Middlebury	Connecticut
United States	Integrity Medical Research	Mountlake Terrace	Washington
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Vanderbilt University medical Center	Nashville	Tennessee
United States	New York University School of Medecine	New York	New York
United States	University Urology	New York	New York
United States	California Professionnal Research	Newport Beach	California
United States	Florida Healthcare Research	Ocala	Florida
United States	Quality Clinical Research	Omaha	Nebraska
United States	Kansas City Urology Care	Overland Park	Kansas
United States	Four Rivers Clinical Research	Paducah	Kentucky
United States	Hudson Valley Urology	Poughkeepsie	New York
United States	Michigan Institute of Urology	Saint Clair Shores	Michigan
United States	Metropolitan Urological Specialists	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	Urology San Antonio Research, PA	San Antonio	Texas
United States	William G. Moseley	San Diego	California
United States	Florida Urologist Specialists	Sarasota	Florida
United States	Southeastern Research Group	Tallahassee	Florida
United States	West Coast Clinical Research	Tarzana	California
United States	Western Clinical Research, Inc.	Torrance	California
United States	Delaware Valley Urology, LLC	Westampton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
AEterna Zentaris

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Prostate Symptoms Score (IPSS)	The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 points (best) to 35 points (worst)	Baseline and 52 weeks
Secondary	Time Course of Quality of Life	The time course of quality of life: assessed by the following disease specific quality of life:"If you were to spend the rest of your life with the urinary conditions just the way it is now, how would you feel about that?" The rating scale is comprising a range of values from 0 to 6, with = delighted, 1 = pleased, 2 = mostly satisfied, 3 = mixed, 4 = mostly dissatisfied, 5 = unhappy, 6 = terrible.	Quality of life assessment in the following weeks: 4,12,26,30,38,46,52