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Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00667446
First received: April 24, 2008
Last updated: January 8, 2014
Last verified: January 2014
History of Changes
Results First Received: October 16, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Precocious
Leuprolide Acetate
Luteinizing Hormone (LH)
Gonadotrophin-releasing Hormone Agonist (GnRHa)
Tanner Staging
Depot Formulation
Suppression of LH
Central Precocious Puberty (CPP)
Gonadotrophin-releasing Hormone (GnRH)
Lupron
GnRH Analog
Pediatrics Central Precocious Puberty
Intervention: Drug: Leuprolide Acetate 3 Month Depot

  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
Participants who successfully completed and showed maintenance of luteinizing hormone suppression through the 6-month treatment period of the lead-in study L-CP07-167 (NCT00635817) received the same treatment in this study that they were previously assigned in the lead-in study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At the end of the Treatment Period, participants who completed the study or prematurely discontinued from the study could enter the Safety Follow-Up Period.

Reporting Groups
  Description
Leuprolide Acetate 3M Depot 11.25 mg Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart during the Treatment Period. During the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
Leuprolide Acetate 3M Depot 30 mg Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart during the Treatment Period. During the the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.

Participant Flow for 2 periods

 Period 1:   Treatment Period (36 Months)
    Leuprolide Acetate 3M Depot 11.25 mg     Leuprolide Acetate 3M Depot 30 mg  
STARTED     34     38  
COMPLETED     11     13  
NOT COMPLETED     23     25  
Ready to enter puberty based on age                 13                 15  
Other                 2                 2  
Personal reasons                 2                 2  
Withdrawal by Subject                 0                 4  
Not Adequately Suppressed on Therapy                 3                 0  
Lost to Follow-up                 1                 0  
Protocol Violation                 1                 1  
Therapeutic Failure                 1                 1  

Period 2:   Safety Follow-up Period (12 Weeks)
    Leuprolide Acetate 3M Depot 11.25 mg     Leuprolide Acetate 3M Depot 30 mg  
STARTED     28     26  
COMPLETED     28     25  
NOT COMPLETED     0     1  
No Longer Needed Treatment                 0                 1  



  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.
Participants who received at least 1 dose of study drug in this extension study.

Reporting Groups
  Description
Leuprolide Acetate 3M Depot 11.25 mg Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
Leuprolide Acetate 3M Depot 30 mg Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Total Total of all reporting groups

Baseline Measures
    Leuprolide Acetate 3M Depot 11.25 mg     Leuprolide Acetate 3M Depot 30 mg     Total  
Number of Participants  
[units: participants]
 		  34     38     72  
Age  
[units: years]
Mean (Standard Deviation) 		  8.50  (1.71)     8.45  (1.52)     8.47  (1.60)  
Gender  
[units: participants]
 		     
Female     32     33     65  
Male     2     5     7  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone   [ Time Frame: Day 1, Months 6, 12, 24, and 36 ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)   [ Time Frame: Day 1, Months 3, 6, 9, 12, and 24 ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)   [ Time Frame: Months 6, 9, 12, 24, 30, and 36 ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Male Participants With Suppression of Basal Testosterone   [ Time Frame: Day 1, Months 3, 6, 9, 12, 24, 30, and 36 ]
  Show Outcome Measure 4

5.  Secondary:   Mean Peak-stimulated Luteinizing Hormone Concentration by Visit   [ Time Frame: Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)   [ Time Frame: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)   [ Time Frame: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in Growth Rate   [ Time Frame: Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36 ]
  Show Outcome Measure 8

9.  Secondary:   Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age   [ Time Frame: Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36 ]
  Show Outcome Measure 9


  Serious Adverse Events
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  Other Adverse Events
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  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: Global Medical Services
Organization: AbbVie, (prior sponsor, Abbott)
phone: 800-633-9110


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00667446     History of Changes
Other Study ID Numbers: L-CP07-177
Study First Received: April 24, 2008
Results First Received: October 16, 2013
Last Updated: January 8, 2014
Health Authority: United States: Food and Drug Administration