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

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.