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Study of Lupron Depot In The Treatment of Central Precocious Puberty

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00660010
First received: April 15, 2008
Last updated: April 8, 2011
Last verified: April 2011
History of Changes
Results First Received: April 22, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Puberty, Precocious
Intervention: Drug: Lupron (leuprolide acetate)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study included 1 treatment group and subjects were assigned the initial dosage depending on their weight. The minimum starting dose was 7.5 mg every 28 days. Study drug was discontinued either when puberty occurred at 12 years +- 6 months for males and 11 years +- 6 months for females or at the discretion of the investigator.

Reporting Groups
  Description
Leuprolide Acetate 1 Month Depot Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.

Participant Flow:   Overall Study
    Leuprolide Acetate 1 Month Depot  
STARTED     55  
COMPLETED     46  
NOT COMPLETED     9  
Withdrawal by Subject                 2  
Lost to Follow-up                 3  
Adverse Event                 1  
Noncompliance with visit schedule                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Leuprolide Acetate 1 Month Depot Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.

Baseline Measures
    Leuprolide Acetate 1 Month Depot  
Number of Participants  
[units: participants]
 		  55  
Age  
[units: subjects]
 		 
<=18 years     55  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  6.9  ± 1.86  
Gender  
[units: subjects]
 		 
Female     49  
Male     6  
Region of Enrollment  
[units: subjects]
 		 
United States     55  



  Outcome Measures
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1.  Primary:   Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)   [ Time Frame: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)   [ Time Frame: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit ]
  Show Outcome Measure 2

3.  Secondary:   Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations   [ Time Frame: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit ]
  Show Outcome Measure 3

4.  Secondary:   Mean Stimulated Estradiol Concentrations in Females   [ Time Frame: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit ]
  Show Outcome Measure 4

5.  Secondary:   Mean Stimulated Testosterone Concentrations in Males   [ Time Frame: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit ]
  Show Outcome Measure 5

6.  Secondary:   Mean Ratio of Bone Age to Chronological Age   [ Time Frame: Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit ]
  Show Outcome Measure 6

7.  Other Pre-specified:   Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL)   [ Time Frame: Final ht. (measured or provided for final questionnaire in subjects >= 18 years of age) or near final adult ht. (<1 cm/year or bone age > 14 years for females or > 15 years for males) ]
  Hide Outcome Measure 7

Measure Type Other Pre-specified
Measure Title Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL)
Measure Description Height was measured by stadiometer and was standardized for age according to standard growth charts. A standardized score of 0 indicated a mean ht. equivalent to mean of a standard population from 2000 CDC standardized ht. charts. Height gain was calculated as ht. - predicted ht. from the Bayley-Pinneau method on the basis of bone age at baseline. Final adult ht. was determined by measurement at final adult ht., if available, or by ht. collected during the follow-up period associated with a growth velocity <1 cm/year or a bone age >14 yrs in females or >15 yrs in males.
Time Frame Final ht. (measured or provided for final questionnaire in subjects >= 18 years of age) or near final adult ht. (<1 cm/year or bone age > 14 years for females or > 15 years for males)  
Safety Issue No  

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.
For the follow-up posttreatment period, the ITT population=40 subjects and the safety population=55 subjects who received at least 1 injection of study drug during the treatment period. Study drug was discontinued at the initiation of puberty. The mean age of subjects at final questionnaire completion was 24.76 years with a range of 18.87 to 26.66.

Reporting Groups
  Description
Leuprolide Acetate 1 Month Depot Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.

Measured Values
    Leuprolide Acetate 1 Month Depot  
Number of Participants Analyzed  
[units: participants]
 		  40  
Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL)  
[units: cm]
Mean ± Standard Error 		 
Near final adult ht. standardized score N=33     -0.2  ± 1.20  
Near final ht.gain from predicted ht. at BL N=29     3.2  ± 5.37  
Final adult ht.standardized score N=19     0.0  ± 1.13  
Final adult ht.gain from predicted ht. at BL N=17     3.9  ± 5.05  

No statistical analysis provided for Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL)



8.  Other Pre-specified:   Mean Time to or Mean Age at Regular Menses in Females After Treatment   [ Time Frame: Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels) ]
  Show Outcome Measure 8

9.  Other Pre-specified:   Number of Female Subjects Who Reported Regular Menses at Adulthood   [ Time Frame: Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) ]
  Show Outcome Measure 9

10.  Other Pre-specified:   Number of Subjects Who Reported Pregnancies at Final Questionnaire   [ Time Frame: Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) ]
  Show Outcome Measure 10

11.  Other Pre-specified:   Number of Pregnancies Reported by Subjects at Final Questionnaire   [ Time Frame: Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) ]
  Show Outcome Measure 11


  Serious Adverse Events
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  Other Adverse Events
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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.


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
Study drug was discontinued usually at the initiation of puberty (12 years for males and 11 years for females) with the concurrence of the investigator, or at the discretion of the investigator. Adverse events are coded with the COSTART dictionary.  


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott Laboratories
phone: 800-633-9110


No publications provided


Responsible Party: Kristof Chwalisz, MD, PhD Therapeutic Area Head, Abbott
ClinicalTrials.gov Identifier: NCT00660010     History of Changes
Other Study ID Numbers: M90-516
Study First Received: April 15, 2008
Results First Received: April 22, 2010
Last Updated: April 8, 2011
Health Authority: United States: Food and Drug Administration