Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients
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ClinicalTrials.gov Identifier: NCT00570011 |
Recruitment Status
:
Completed
First Posted
: December 10, 2007
Last Update Posted
: December 11, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Growth Hormone Deficiency | Drug: Somatropin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 112 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult Patients |
Study Start Date : | June 1997 |
Actual Study Completion Date : | December 1998 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Somatropin
3 microg/kg/day for the first three months.The dose was then doubled (6 microg/kg/day) for the next three-months.
Other Name: LLY137998
|
Experimental: 2 |
Drug: Somatropin
6 microg/kg/day for the first three months. The dose was then doubled (12 microg/kg/day) for the next three-months.
Other Name: LLY137998
|
- 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 ]
- Serum concentrations of Leptin, Insulin, IGFBP1, IGFBP2, IGF2 [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570011
United States, Indiana | |
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 |
Study Director: | 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) | Eli Lilly and Company |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00570011 History of Changes |
Other Study ID Numbers: |
822 B9R-EW-GDED |
First Posted: | December 10, 2007 Key Record Dates |
Last Update Posted: | December 11, 2007 |
Last Verified: | December 2007 |
Additional relevant MeSH terms:
Dwarfism, Pituitary Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |