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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00570011
• Date of registration: 07/12/2007
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• Public title: Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients
• Scientific title: Efficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult Patients
• Date of first enrolment: June 1997
• Target sample size: 112
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00570011
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria:

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,
or,

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.

Exclusion Criteria:

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Drug: Somatropin

Primary Outcome(s)

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

Secondary Outcome(s)

Serum concentrations of Leptin, Insulin, IGFBP1, IGFBP2, IGF2 [Time Frame: 6 months]

Secondary ID(s)

B9R-EW-GDED

822

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Naples

University of Pisa

University of Milan

University of Padua