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Study of Lupron Depot In The Treatment of Central Precocious Puberty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00660010
First Posted: April 17, 2008
Last Update Posted: April 12, 2011
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:
Abbott
Results First Submitted: April 22, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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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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
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 
Overall Participants Analyzed 
[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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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) ]

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) ]

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) ]

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) ]

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) ]


  Serious Adverse Events
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Time Frame Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued.
Additional Description Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.

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.

Serious Adverse Events
    Leuprolide Acetate 1 Month Depot
Total, Serious Adverse Events   
# participants affected / at risk   7/55 (12.73%) 
Cardiac disorders   
Heart arrest 1 [2]   
# participants affected / at risk   1/55 (1.82%) 
General disorders   
Aggravation reaction 1 [3]   
# participants affected / at risk   1/55 (1.82%) 
Infections and infestations   
Infection 1 [3]   
# participants affected / at risk   1/55 (1.82%) 
Pneumonia 1 [4]   
# participants affected / at risk   1/55 (1.82%) 
Musculoskeletal and connective tissue disorders   
Bone Disorder 1 [5]   
# participants affected / at risk   1/55 (1.82%) 
Pathological fracture 1 [5]   
# participants affected / at risk   1/55 (1.82%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Carcinoma 1 [3]   
# participants affected / at risk   1/55 (1.82%) 
Psychiatric disorders   
Personality disorder 1 [6]   
# participants affected / at risk   1/55 (1.82%) 
Respiratory, thoracic and mediastinal disorders   
Asthma 1 [4]   
# participants affected / at risk   1/55 (1.82%) 
Surgical and medical procedures   
Repair of ventriculoperitoneal shunt 1 [7]   
# participants affected / at risk   1/55 (1.82%) 
1 Term from vocabulary, COSTART
[2] COSTART body system is cardiovascular system
[3] COSTART body system is body as a whole
[4] COSTART body system is respiratory system
[5] COSTART body system is musculoskeletal system
[6] COSTART body system is nervous system
[7] COSTART body system was not classified since it was a surgical repair.




  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
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.


  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: Abbott Laboratories
phone: 800-633-9110


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

Responsible Party: Kristof Chwalisz, MD, PhD Therapeutic Area Head, Abbott
ClinicalTrials.gov Identifier: NCT00660010     History of Changes
Other Study ID Numbers: M90-516
First Submitted: April 15, 2008
First Posted: April 17, 2008
Results First Submitted: April 22, 2010
Results First Posted: July 20, 2010
Last Update Posted: April 12, 2011