Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004141

Trial Description

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Title

Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-blind Placebo-controlled Efficacy Study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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).

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004141
  •   2012/10/17
  •   2008/04/17
  •   no
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Secondary IDs

  •   NCT00663858  (ClinicalTrials.gov)
  •   AEZS-102-036  (AEterna Zentaris)
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Health Condition or Problem studied

  •   Benign Prostatic Hypertrophy
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Drug: Cetrorelix 78+78
  •   Drug: Cetrorelix 78 + Placebo
  •   Other: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- 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)

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Secondary Outcome

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Countries of Recruitment

  •   Belarus
  •   Bulgaria
  •   Czech Republic
  •   France
  •   Germany
  •   Italy
  •   Macedonia, the former Yugoslav Republic of
  •   Netherlands
  •   Romania
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2008/03/31
  •   420
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   50   Years
  •   no maximum age
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Additional Inclusion Criteria

- Benign Prostatic Hyperplasia, based on medical history

- Voiding symptoms

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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

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Addresses

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    • AEterna Zentaris
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    • Andros Mannenkliniek, Arnhem, The Netherlands
    • Frans MJ Debruyne, M.D. 
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    • Andros Mannenkliniek, Arnhem, The Netherlands
    • Frans MJ Debruyne, M.D. 
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    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2010/01/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.