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

Phase 3

Completed

• Conditions: Benign Prostatic Hypertrophy
• Interventions: Drug: Cetrorelix Pamoate

• Registration Number: NCT00670306
• Lead Sponsor: AEterna Zentaris

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

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-22
• Study First Submitted QC: 2008-04-29
• Study First Posted: 2008-05-01
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2010-10-18
• Results First Submitted QC: 2010-12-15
• Results First Posted: 2011-01-19
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-01
• Last Update Posted: 2011-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 528

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cetrorelix 78 mg	Cetrorelix Pamoate	Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.

Primary Outcome Measures

Name	Time	Method
IPSS Change From Baseline	Baseline and Week 26	International Prostate Symptom Score (IPSS) 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 - 35 points; absolute change from baseline to Week 26

Trial Locations

Locations (69)

Urology Centers of Alabama; 🇺🇸 Homewood, Alabama, United States

Medical Affiliated Research Center, Inc.; 🇺🇸 Huntsville, Alabama, United States

South Orange County Medical Research Center; 🇺🇸 Laguna Hills, California, United States

California Professionnal Research; 🇺🇸 Newport Beach, California, United States

Northern California Research; 🇺🇸 Sacramento, California, United States

San Diego Uro Research; 🇺🇸 San Diego, California, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

West Coast Clinical Research; 🇺🇸 Tarzana, California, United States

Genitourinary Surgical Consultants; 🇺🇸 Denver, Colorado, United States

Connecticut Clincal Research Center, LLC; 🇺🇸 Middlebury, Connecticut, United States

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