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

Completed · Phase 3

Conditions studied: Growth Hormone Deficiency

In brief

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.

Key facts

Study ID

NCT00570011

Run by

Eli Lilly and Company

People needed

112

Starts

1997-06-01

Expected to finish

1998-12-01

Last updated by the study team

2007-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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