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

This study has been completed.
Sponsor:
Information provided by:
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT00663858
First received: April 17, 2008
Last updated: December 15, 2010
Last verified: December 2010
  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 78+78
Drug: Cetrorelix 78 + Placebo
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-blind Placebo-controlled Efficacy Study

Resource links provided by NLM:


Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:
  • International Prostate Symptom Score (IPSS) [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    IPSS score of BPH symptoms 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 overall score range: 0 points (best) to 35 points (worst)


Enrollment: 420
Study Start Date: March 2008
Study Completion Date: January 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetrorelix 78+78 Drug: Cetrorelix 78+78
Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
Experimental: Cetrorelix 78 + Placebo Drug: Cetrorelix 78 + Placebo
Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28
Placebo Comparator: Placebo Other: Placebo
Placebo on Week 0, Week 2, Week 26 and Week 28

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663858

  Show 55 Study Locations
Sponsors and Collaborators
AEterna Zentaris
Investigators
Study Chair: Frans MJ Debruyne, M.D. Andros Mannenkliniek, Arnhem, The Netherlands
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00663858     History of Changes
Other Study ID Numbers: AEZS-102-036
Study First Received: April 17, 2008
Results First Received: November 11, 2010
Last Updated: December 15, 2010
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

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hypertrophy
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical
Cetrorelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014