Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study Initiation and Completion Dates: 26 May 2008 to 17 October 2008. The study was terminated prematurely.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Nine patients were enrolled, but no patients were randomized due to early termination of study.

Reporting Groups

	Description
Placebo	No text entered.
Somatropin	Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.

Participant Flow:   Overall Study

	Placebo	Somatropin
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Reporting Groups

	Description
Placebo	No text entered.
Somatropin	Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.

Baseline Measures

	Placebo	Somatropin	Total
Number of Participants   [units: participants]	0	0	0
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Gender   [units: participants]
Female	0	0	0
Male	0	0	0

1.  Primary:

Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)   [ Time Frame: Baseline, 52 weeks ]

2.  Secondary:

Change in Visceral Fat Mass in Subgroups   [ Time Frame: Baseline, 52 weeks, 78 weeks ]

3.  Secondary:

Change From Baseline in Anthropometric Parameters (Height)   [ Time Frame: Baseline, 52 weeks, 78 weeks ]

4.  Secondary:

Change From Baseline in Anthropometric Parameters (Weight)   [ Time Frame: Baseline, 52 weeks, 78 weeks ]

5.  Secondary:

Change From Baseline in Anthropometric Parameters (Waist Circumference)   [ Time Frame: Baseline, 52 weeks, 78 weeks ]

6.  Secondary:

Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT])   [ Time Frame: Baseline, Week 52, Week 78 ]

7.  Secondary:

Change From Baseline in Blood Pressure   [ Time Frame: Baseline, Week 52, Week 78 ]

8.  Secondary:

Change From Baseline in Heart Rate   [ Time Frame: Baseline, Week 52, Week 78 ]

9.  Secondary:

Change in Executive Function and Memory in Subgroups   [ Time Frame: Baseline, Week 52, Week 78 ]

10.  Secondary:

Change From Baseline in Safety Laboratory Assessments   [ Time Frame: Baseline, Week 52, Week 78 ]

11.  Secondary:

Change From Baseline in Homeostasis Model Assessment (HOMA)-Index   [ Time Frame: Baseline, Week 52, Week 78 ]

12.  Secondary:

Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA)   [ Time Frame: Baseline, Week 52, Week 78 ]

13.  Secondary:

Change From Baseline in Short Form (36) Health Survey (SF36)   [ Time Frame: Baseline, Week 52, Week 78 ]

14.  Secondary:

Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D)   [ Time Frame: Baseline, Week 52, Week 78 ]

15.  Secondary:

Change From Baseline in Cardiovascular Risk Factors   [ Time Frame: Baseline, Week 52, Week 78 ]