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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00670306
Recruitment Status : Completed
First Posted : May 1, 2008
Results First Posted : January 19, 2011
Last Update Posted : April 5, 2011
Sponsor:
Information provided by:
AEterna Zentaris

Study Description
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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).


Condition or disease Intervention/treatment Phase
Benign Prostatic Hypertrophy Drug: Cetrorelix Pamoate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 528 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study
Study Start Date : March 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cetrorelix 78 mg
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
Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,
Other Name: Cetrorelix pamoate, D-20762, AEZS-102


Outcome Measures
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Primary Outcome Measures :
  1. IPSS Change From Baseline [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670306


Locations
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Sponsors and Collaborators
AEterna Zentaris
More Information
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Responsible Party: Daniel Croteau / Medical Manager, AEterna Zentaris
ClinicalTrials.gov Identifier: NCT00670306    
Other Study ID Numbers: AEZS-102-Z041
First Posted: May 1, 2008    Key Record Dates
Results First Posted: January 19, 2011
Last Update Posted: April 5, 2011
Last Verified: April 2011
Keywords provided by AEterna Zentaris:
Cetrorelix
BPH
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hypertrophy
Pathological Conditions, Anatomical
Prostatic Diseases
Cetrorelix
Fertility Agents, Female
 Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists