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Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01467882
First Posted: November 9, 2011
Last Update Posted: July 28, 2017
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):
Debiopharm International SA
Results First Submitted: June 25, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Central Precocious Puberty
Intervention: Drug: Triptorelin

  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
Intention to treat, defined as all participants enrolled

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
Children All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169

Participant Flow:   Overall Study
    Children
STARTED   44 
COMPLETED   44 
NOT COMPLETED   0 



  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.
Intention to treat, defined as all participants enrolled

Reporting Groups
  Description
Children All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169

Baseline Measures
   Children 
Overall Participants Analyzed 
[Units: Participants]
 44 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      44 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 7.41  (1.28) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      39  88.6% 
Male      5  11.4% 
Region of Enrollment 
[Units: Participants]
 
United States   28 
Mexico   1 
Chile   15 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6   [ Time Frame: Month 6 ]

2.  Secondary:   Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12   [ Time Frame: at Months 1, 2, 3, 9 and 12 ]

3.  Secondary:   Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation From Month 6 to 12   [ Time Frame: from Month 6 to 12 ]

4.  Secondary:   Percentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 6, 9 and 12   [ Time Frame: at Months 1, 2, 3, 6, 9 and 12 ]

5.  Secondary:   Percentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation From Month 6 to 12   [ Time Frame: from Month 6 to 12 ]

6.  Secondary:   Change From Baseline in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at Months 1, 2, 3, 6, 9, and 12   [ Time Frame: Baseline to Months 1, 2, 3, 6, 9, and 12 ]

7.  Secondary:   Change From Baseline in Estradiol Levels at Months 1, 2, 3, 6, 9, and 12   [ Time Frame: Baseline to Months 1, 2, 3, 6, 9, and 12 ]

8.  Secondary:   Change From Baseline in Testosterone Levels at Months 1, 2, 3, 6, 9, and 12   [ Time Frame: Baseline to Months 1, 2, 3, 6, 9, and 12 ]

9.  Secondary:   Percentage of Children With Prepubertal Estradiol or Testosterone Levels at Months 1, 2, 3, 6, 9, and 12   [ Time Frame: at Months 1, 2, 3, 6, 9, and 12 ]

10.  Secondary:   Percentage of Children Without Higher Basal LH and Estradiol or Testosterone   [ Time Frame: at 2 days after second triptorelin injection (Day 171) ]

11.  Secondary:   Change From Baseline in Height-for-age Z-score Per 2000 CDC Growth Charts at Months 6 and 12   [ Time Frame: Baseline to Months 6 and 12 ]

12.  Secondary:   Change From Baseline in Height-for-age Percentile Per 2000 CDC Growth Charts at Months 6 and 12   [ Time Frame: Baseline to Months 6 and 12 ]

13.  Secondary:   Change From Baseline in Growth Velocity at Months 6 and 12   [ Time Frame: Baseline to Months 6 and 12 ]

14.  Secondary:   Percentage of Participants Without Bone Age / Chronological Age Ratio Increase From Baseline at Months 6 and 12   [ Time Frame: Baseline to Months 6 and 12 ]

15.  Secondary:   Percentage of Children Achieving Stabilization of Sexual Maturation at Months 6 and 12   [ Time Frame: at Months 6 and 12 ]

16.  Secondary:   Percentage of Girls With Regression of Uterine Length Compared to Baseline at Months 6 and 12   [ Time Frame: Baseline to Months 6 and 12 ]

17.  Secondary:   Percentage of Boys With Absence of Progression of Testis Volumes Compared to Baseline at Months 6 and 12   [ Time Frame: Baseline to Months 6 and 12 ]


  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 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.


Results Point of Contact:  
Name/Title: Eija Lundström
Organization: Debiopharm International, S.A.
phone: :+41 21 3210111
e-mail: eija.lundstrom@debiopharm.com


Publications:

Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01467882     History of Changes
Other Study ID Numbers: Debio 8206-CPP-301
First Submitted: November 7, 2011
First Posted: November 9, 2011
Results First Submitted: June 25, 2015
Results First Posted: September 4, 2015
Last Update Posted: July 28, 2017