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.
Patients may be included in the study only if they meet all of the following criteria:
1. 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,
2. Adult males and females with GHD either idiopathic or secondary to pituitary disease
arising in childhood.
3. 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.
4. Receiving replacement for other deficient hormones for at least 3 months prior to the
start of the study, where necessary.
5. Have given informed consent.
Patients will be excluded from the study for any of the following reasons:
1. Patients with clinically significant pulmonary, cardiac, hepatic, renal or
neuromuscular disease or with chromosomal or genetic malformation syndromes.
2. Patients who have any evidence of an active tumorous process. Intercranial lesions
must be inactive and any antitumour therapy must be complete.
3. Pregnant women and lactating females or women who decide to become pregnant during
the study and who are not taking adequate contraceptives.
4. Patients thought unlikely to comply with the protocol.
5. Patients taking an investigational drug in the previous month.