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OpenTrials
Completed

NCT Number: NCT00670306

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

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).

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Key information

Conditions

Benign Prostatic Hypertrophy Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Can-Med Clinical Research Inc., Victoria, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetrorelix Pamoate

Drug

Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,

Other names: Cetrorelix pamoate, D-20762, AEZS-102

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

AEterna Zentaris

Industry

Registry information

Official study title

Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study

Acronym: AEZS-102-Z041

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 1, 2008
Registry last updated
Apr 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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