Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients

Study Overview
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Brief Summary
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An international study in which patients with GHD were randomized to receive somatropin at a dose of either 3 microg/kg/day or 6 microg/kg/day for the first three months. The dose was then doubled (6 microg/kg/day, LD or 12 microg/kg/day, CD) for the next three-months.

Official Title
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Efficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult Patients

Conditions
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Growth Hormone Deficiency

Intervention / Treatment
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* Drug: Somatropin
* Drug: Somatropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients may be included in the study only if they meet all of the following criteria: Adult males and females with GHD, arising during adult life from pituitary ablation or failure, onset of GHD have taken place at least 1 year before entering the study, or, Adult males and females with GHD either idiopathic or secondary to pituitary disease arising in childhood. Demonstrated GHD as documented by a negative response to a standard GH stimulation test within the last 5 years previous year (see Section 3.4.3, part b). Maximal peak must be less than 3.0 ng/ml. Receiving replacement for other deficient hormones for at least 3 months prior to the start of the study, where necessary. Have given informed consent. Exclusion Criteria: Patients will be excluded from the study for any of the following reasons: Patients with clinically significant pulmonary, cardiac, hepatic, renal or neuromuscular disease or with chromosomal or genetic malformation syndromes. Patients who have any evidence of an active tumorous process. Intercranial lesions must be inactive and any antitumour therapy must be complete. Pregnant women and lactating females or women who decide to become pregnant during the study and who are not taking adequate contraceptives. Patients thought unlikely to comply with the protocol. Patients taking an investigational drug in the previous month.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Somatropin<br>* 3 microg/kg/day for the first three months.The dose was then doubled (6 microg/kg/day) for the next three-months.<br>* Other names: LLY137998;|
| Experimental: 2<br> | Drug: Somatropin<br>* 6 microg/kg/day for the first three months. The dose was then doubled (12 microg/kg/day) for the next three-months.<br>* Other names: LLY137998;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasminogen activator inhibitor-1 (PAI-1) and tissue plasminogen activator (t-PA) as a function of changes in insulin levels was investigated. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentrations of Leptin, Insulin, IGFBP1, IGFBP2, IGF2 |  | 6 months |