Trial document

This study has been imported from without additional data checks.
drksid header


Trial Description

start of 1:1-Block title


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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym


end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial


end of 1:1-Block url
start of 1:1-Block public summary

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).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language


end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004141
  •   2012/10/17
  •   2008/04/17
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT00663858  (
  •   AEZS-102-036  (AEterna Zentaris)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Benign Prostatic Hypertrophy
  •   N40 -  Hyperplasia of prostate
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: Cetrorelix 78+78
  •   Drug: Cetrorelix 78 + Placebo
  •   Other: Placebo
end of 1:N-Block interventions
start of 1:1-Block design


  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

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)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome


end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Belarus
  •   Bulgaria
  •   Czech Republic
  •   France
  •   Germany
  •   Italy
  •   Macedonia, the former Yugoslav Republic of
  •   Netherlands
  •   Romania
  •   United Kingdom
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   [---]*
  •   2008/03/31
  •   420
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   50   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Benign Prostatic Hyperplasia, based on medical history

- Voiding symptoms

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Urgent need for prostate surgery or prior surgical treatment of the prostate or

- 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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses


  • start of 1:1-Block address primary-sponsor
    • AEterna Zentaris
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Andros Mannenkliniek, Arnhem, The Netherlands
    • Frans MJ Debruyne, M.D. 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Andros Mannenkliniek, Arnhem, The Netherlands
    • Frans MJ Debruyne, M.D. 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state


  •   Recruiting complete, follow-up complete
  •   2010/01/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in and DRKS are not identical. Therefore the data import from 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.