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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
History of Changes
Results First Received: November 11, 2010  
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
Condition: Benign Prostatic Hypertrophy
Interventions: Drug: Cetrorelix 78+78
Drug: Cetrorelix 78 + Placebo
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cetrorelix 78+78 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
CET 78+Placebo 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
Placebo Placebo on Week 0, 2, 26 and 28.

Participant Flow:   Overall Study
    Cetrorelix 78+78     CET 78+Placebo     Placebo  
STARTED     212     106     102  
COMPLETED     178     96     82  
NOT COMPLETED     34     10     20  
Adverse Event                 9                 1                 6  
Lack of Efficacy                 5                 1                 3  
Withdrawal by Subject                 7                 3                 3  
Protocol Violation                 5                 3                 4  
Unknown                 8                 2                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Cetrorelix 78+78 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
CET 78+Placebo 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
Placebo Placebo on Week 0, 2, 26 and 28.
Total Total of all reporting groups

Baseline Measures
    Cetrorelix 78+78     CET 78+Placebo     Placebo     Total  
Number of Participants  
[units: participants]
 		  212     106     102     420  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     101     45     37     183  
>=65 years     111     61     65     237  
Age  
[units: years]
Mean ± Standard Deviation 		  66.58  ± 8.16     66.50  ± 7.29     67.72  ± 7.17     66.83  ± 7.71  
Gender  
[units: participants]
 		       
Female     0     0     0     0  
Male     212     106     102     420  
Region of Enrollment  
[units: participants]
 		       
France     0     1     0     1  
Belarus     37     18     18     73  
Czech Republic     33     15     19     67  
Macedonia, The Former Yugoslav Republic of     6     3     3     12  
Romania     54     28     26     108  
Bulgaria     41     20     20     81  
Germany     15     7     6     28  
Netherlands     23     13     10     46  
United Kingdom     1     0     0     1  
Italy     2     1     0     3  



  Outcome Measures

1.  Primary:   International Prostate Symptom Score (IPSS)   [ Time Frame: Baseline and 52 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Herbert Sindermann
Organization: Aeterna Zentaris
phone: +49 69 42602 3429
e-mail: HSindermann@aezsinc.com


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