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Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study (DECAPUB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00909844
First received: May 28, 2009
Last updated: March 17, 2017
Last verified: March 2017
Results First Received: December 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Precocious Puberty
Intervention: Drug: Triptorelin (I.N.N.)

  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
The study was designed as a multicentre study and included 10 investigational sites in France. This follow up study was to start on the day of the last visit (Month 6) of the phase III 2-54-52014-143 study and was to end when the Investigator judged that the patient had completed his/her treatment, i.e. at around 11 years in girls and 13 in boys.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A maximum of 35 patients could be included in this study (i.e. the number of patients who had completed the phase III 2-54-52014-143 study). A total of 35 patients were screened and enrolled in this current study (2-54-52014-159).

Reporting Groups
  Description
Triptorelin Pamoate 11.25 mg 11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.

Participant Flow:   Overall Study
    Triptorelin Pamoate 11.25 mg
STARTED   35 
COMPLETED   31 
NOT COMPLETED   4 
Adverse Event                1 
Withdrawal by Subject                1 
Lost to Follow-up                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.
Baseline characteristics are presented for Intention-To-Treat Population (ITT) population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. These data were not re-collected at the start of the current study and are derived from data collected at Baseline of study 2-54-52014-143.

Reporting Groups
  Description
Triptorelin Pamoate 11.25 mg 11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.

Baseline Measures
   Triptorelin Pamoate 11.25 mg 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.73  (1.07) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      34  97.1% 
Male      1   2.9% 
Weight at Pretreatment 
[Units: Kilogram (kg)]
Mean (Standard Deviation)
 32.4  (6.9) 


  Outcome Measures
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1.  Primary:   Percentage of Children With a Stabilisation or Regression of Tanner Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)   [ Time Frame: Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months) ]

2.  Secondary:   Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test   [ Time Frame: Months -6, 0 and 36 ]

3.  Secondary:   Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA)   [ Time Frame: Months -6, 0, 12, 36 and Final Visit (up to 63 months) ]

4.  Secondary:   Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test   [ Time Frame: Months -6, 0 and 36 ]

5.  Secondary:   Body Mass Index (BMI) for Chronological Age Variation   [ Time Frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) ]

6.  Secondary:   BMI Standard Deviation (SD) Score for Chronological Age Variation   [ Time Frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) ]

7.  Secondary:   Auxological Parameters Variations: Height SD Score   [ Time Frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) ]

8.  Secondary:   Auxological Parameters Variations: Growth Velocity SD Score   [ Time Frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) ]

9.  Secondary:   Auxological Parameters Variations: Weight Variation   [ Time Frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) ]

10.  Secondary:   Predicted Adult Height SD Score   [ Time Frame: Months -6, 0, 12 and Final Visit (up to 63 months) ]

11.  Secondary:   Bone Age Maturation   [ Time Frame: Months -6, 0 and Final Visit (up to 63 months) ]

12.  Secondary:   Percentage of Girls With a Uterine Length < 36 Millimetres (mm)   [ Time Frame: Months -6, 0, 12, 24, 36 and Final Visit (up to 63 months) ]

13.  Secondary:   Percentage of Children With a Stabilisation or Regression of Tanner Pubic Hair Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)   [ Time Frame: Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months) ]

14.  Post-Hoc:   Percentage of Girls With a Stabilisation or Regression of Tanner Breast Pubertal Stage at the End of the Study (Last Visit on Treatment), Compared to Pretreatment (Month -6) and Baseline (Month 0)   [ Time Frame: Months 12, 24, 36, 48 and Last Visit on Treatment (if applicable; up to 51 months) ]

15.  Post-Hoc:   Percentage of Children With a Stabilisation or Regression of Tanner Pubic Hair Pubertal Stage at the End of the Study (Last Visit on Treatment), Compared to Pretreatment (Month -6)   [ Time Frame: Months 12, 24, 36, 48 and Last Visit on Treatment (if applicable; up to 51 months) ]


  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
Since almost no hormonal data was collected after Baseline and only limited data was collected after Baseline for all other efficacy endpoints, only limited post-Baseline data is reported for the trial overall. All data analysed has been presented.


  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 Pharma
e-mail: clinical.trials@ipsen.com



Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00909844     History of Changes
Other Study ID Numbers: 2-54-52014-159
2008-000565-39 ( EudraCT Number )
Study First Received: May 28, 2009
Results First Received: December 28, 2016
Last Updated: March 17, 2017