Text Size

Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH) (AEZS-102-Z041)

This study has been completed.
Sponsor:
Information provided by:
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT00670306
First received: April 22, 2008
Last updated: April 1, 2011
Last verified: April 2011
History of Changes
Results First Received: October 18, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Benign Prostatic Hypertrophy
Intervention: Drug: Cetrorelix Pamoate

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Cetrorelix 78 mg Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.

Participant Flow:   Overall Study
    Cetrorelix 78 mg  
STARTED     528  
COMPLETED     473  
NOT COMPLETED     55  
Adverse Event                 8  
Lack of Efficacy                 10  
Withdrawal by Subject                 9  
Physician Decision                 1  
Lost to Follow-up                 8  
incl/excl criterias did not meet                 19  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Cetrorelix 78 mg Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.

Baseline Measures
    Cetrorelix 78 mg  
Number of Participants  
[units: participants]
 		  528  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     301  
>=65 years     227  
Age  
[units: years]
Mean ± Standard Deviation 		  64.9  ± 8.2  
Gender  
[units: participants]
 		 
Female     0  
Male     528  
Region of Enrollment  
[units: participants]
 		 
United States     414  
Canada     114  



  Outcome Measures

1.  Primary:   IPSS Change From Baseline   [ Time Frame: Baseline and Week 26 ]
  Show Outcome Measure 1


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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 more than 60 days but less than or equal to 180 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
No text entered.  


Results Point of Contact:  
Name/Title: Daniel Croteau, Medical Manager
Organization: AEterna Zentaris
phone: 418-652-7669 ext 272
e-mail: DCroteau@aezsinc.com


No publications provided


Responsible Party: Daniel Croteau / Medical Manager, AEterna Zentaris
ClinicalTrials.gov Identifier: NCT00670306     History of Changes
Other Study ID Numbers: AEZS-102-Z041
Study First Received: April 22, 2008
Results First Received: October 18, 2010
Last Updated: April 1, 2011
Health Authority: United States: Food and Drug Administration