Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study Initiation Date: 06 Jan 2005 (date of first subject, first dose) Study Completion Date 11 Jun 2006 (date of last subject, last visit) 19 study centres in the United States received IRB approval to participate in this study; 13 of the centres enrolled at least one subject into the study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All study screening assessments were to be performed within a 30-day period prior to study entry. A total of 40 subjects were screened for the study and 31 of them (77.5%) were randomised and received study drug.

Reporting Groups

	Description
Standard Dose Group	0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
High Dose Group	0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.

Participant Flow:   Overall Study

	Standard Dose Group	High Dose Group
STARTED	15	16
COMPLETED	13	12
NOT COMPLETED	2	4
Protocol Violation	0	1
Stopped taking study drug	1	1
Non-compliant	0	1
Could not commit time for study	1	1

Reporting Groups

	Description
Standard Dose Group	0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
High Dose Group	0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.

Baseline Measures

	Standard Dose Group	High Dose Group	Total
Number of Participants   [units: participants]	15	16	31
Age   [units: years] Mean ± Standard Deviation	17.4  ± 1.8	18.1  ± 1.9	17.8  ± 1.9
Gender   [units: participants]
Female	5	6	11
Male	10	10	20
Region of Enrollment   [units: participants]
United States	15	16	31
Lean body mass   [units: kg] Mean ± Standard Deviation	44.03  ± 11.09	44.38  ± 12.98	44.21  ± 11.90
Limb fat   [units: kg] Mean ± Standard Deviation	11.47  ± 5.49	12.92  ± 9.28	12.22  ± 7.59
Total body fat   [units: kg] Mean ± Standard Deviation	24.02  ± 10.81	25.11  ± 18.29	24.58  ± 14.90
Trunk fat   [units: kg] Mean ± Standard Deviation	11.73  ± 5.58	11.40  ± 9.09	11.56  ± 7.47
Trunk to limb fat ratio   [units: ratio] Mean ± Standard Deviation	1.05  ± 0.29	0.87  ± 0.17	0.96  ± 0.25

1.  Primary:

% Change From Baseline to Week 24 in Trunk Fat   [ Time Frame: Week 24 ]

2.  Secondary:

% Change From Baseline to Week 24 in Lean Body Mass   [ Time Frame: Week 24 ]

3.  Secondary:

% Change From Baseline to Week 24 in Total Body Fat   [ Time Frame: Week 24 ]

4.  Secondary:

% Change From Baseline to Week 24 in Limb Fat   [ Time Frame: Week 24 ]

5.  Secondary:

% Change From Baseline to Week 24 in Trunk to Limb Fat Ratio   [ Time Frame: Week 24 ]