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

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. Identifier: NCT00663858
Recruitment Status : Completed
First Posted : April 22, 2008
Results First Posted : January 17, 2011
Last Update Posted : January 17, 2011
Information provided by:
AEterna Zentaris

Brief 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).

Condition or disease Intervention/treatment Phase
Benign Prostatic Hypertrophy Drug: Cetrorelix 78+78 Drug: Cetrorelix 78 + Placebo Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-blind Placebo-controlled Efficacy Study
Study Start Date : March 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. International Prostate Symptom Score (IPSS) [ Time Frame: Baseline and 52 weeks ]
    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)

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00663858

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Sponsors and Collaborators
AEterna Zentaris
Study Chair: Frans MJ Debruyne, M.D. Andros Mannenkliniek, Arnhem, The Netherlands Identifier: NCT00663858     History of Changes
Other Study ID Numbers: AEZS-102-036
First Posted: April 22, 2008    Key Record Dates
Results First Posted: January 17, 2011
Last Update Posted: January 17, 2011
Last Verified: December 2010

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathological Conditions, Anatomical
Prostatic Diseases
Genital Diseases, Male
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists