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Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty (DECAPUB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00564850
First Posted: November 28, 2007
Last Update Posted: February 13, 2012
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.
Information provided by (Responsible Party):
Ipsen
Results First Submitted: November 1, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Precocious Puberty
Intervention: Drug: Triptorelin pamoate 11.25mg (Decapeptyl® SR)

  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
62 participants were screened, of which 37 met the study's entry criteria and received at least one dose of investigational medicinal product. 25 participants failed screening. Participants were recruited from October 2007 at 18 Hospital clinics across France.

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
Triptorelin Pamoate 11.25 mg 11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.

Participant Flow:   Overall Study
    Triptorelin Pamoate 11.25 mg
STARTED   37 
COMPLETED   35 
NOT COMPLETED   2 
Protocol Violation                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Triptorelin Pamoate 11.25 mg 11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.

Baseline Measures
   Triptorelin Pamoate 11.25 mg 
Overall Participants Analyzed 
[Units: Participants]
 37 
Age 
[Units: Participants]
 
<=18 years   37 
Between 18 and 65 years   0 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.2  (1.1) 
Gender 
[Units: Participants]
 
Female   36 
Male   1 
Region of Enrollment 
[Units: Participants]
 
France   37 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 32.76  (7.36) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L   [ Time Frame: 3 months after the first injection of triptorelin pamoate 11.25 mg ]

2.  Secondary:   Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L   [ Time Frame: Month 6 ]

3.  Secondary:   Follicle Stimulating Hormone (FSH) Level Following GnRH Test   [ Time Frame: Screening, month 3 and 6 ]

4.  Secondary:   Basal FSH Level   [ Time Frame: Month 0, 1, 2, 3, 4, 5, and 6 ]

5.  Secondary:   Basal LH Level   [ Time Frame: Month 0, 1, 2, 3, 4, 5 and 6 ]

6.  Secondary:   Number of Girls With Oestradiol Levels ≤ 20 pg/ml   [ Time Frame: Month 0, 1, 2, 3, 4, 5 and 6 ]

7.  Secondary:   Testosterone Level   [ Time Frame: Month 0, 3 and 6 ]

8.  Secondary:   Number of Girls With Inhibin B Levels < 6 pg/ml   [ Time Frame: Month 0, 3 and 6 ]

9.  Secondary:   Change From Screening in Pubertal Stage (Tanner Method) at Month 6   [ Time Frame: Between screening and month 6 ]

10.  Secondary:   Height Standard Deviation Score (SDS)   [ Time Frame: Month 0, 3 and 6 ]

11.  Secondary:   Body Mass Index (BMI) SDS   [ Time Frame: Month 0, 3 and 6 ]

12.  Secondary:   Change From Baseline in Growth Velocity (GV) SDS at Month 6   [ Time Frame: Baseline and month 6 ]

13.  Secondary:   Difference Between Bone Age and Chronological Age   [ Time Frame: Month 0 and 6 ]

14.  Secondary:   Uterine Length   [ Time Frame: Month 0, 3 and 6 ]

15.  Secondary:   Triptorelin Plasma Levels   [ Time Frame: Month 1, 2, 3, 4, 5 and 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Medical Director, Endocrinology
Organization: Ipsen
e-mail: clinical.trials@ipsen.com



Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00564850     History of Changes
Other Study ID Numbers: 2-54-52014-143
First Submitted: November 27, 2007
First Posted: November 28, 2007
Results First Submitted: November 1, 2011
Results First Posted: December 1, 2011
Last Update Posted: February 13, 2012