Working… Menu

Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00490191
Recruitment Status : Completed
First Posted : June 22, 2007
Last Update Posted : June 22, 2007
Information provided by:
Eli Lilly and Company

Brief Summary:
This study tested whether a dose regimen of growth hormone based on body weight is equivalent or better than starting with a low dose and gradually increasing the dose according to individual patient needs. Efficacy of the two regimens were assessed from changes in body fat measured by dual-energy x-ray absorptiometry (DXA) scanning, performed at the beginning of the study and at the completion of the study eight months later.

Condition or disease Intervention/treatment Phase
Hypopituitarism Drug: Somatropin Phase 4

Detailed Description:

Dose regimen of growth hormone based on weight: Starting dose was 4.0 micrograms/kg/day for four months, then increased to 8 micrograms/kg/day for two months, and then increased to 12 micrograms/kg/day for a further two months (eight months in total).

Dose regimen of growth hormone based on individual patient needs: Starting dose was 200 micrograms/day, then increased by 200 micrograms/day every two months for an additional six months (eight months in total) as needed for optimal treatment results.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 387 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone Deficiency
Study Start Date : January 1999
Actual Study Completion Date : July 2001

Primary Outcome Measures :
  1. Percent change in total fat mass [ Time Frame: Eight months ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: Eight months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have growth hormone deficiency that started in childhood or adulthood
  • Have not received any growth hormone treatment in the last 12 months
  • Have had a growth hormone stimulation test within the last two years showing abnormally low response
  • Have received adequate and stable hormonal replacement for other hormone deficiencies during the last three months

Exclusion Criteria:

  • Presence of clinically significant diseases, such as cancer, lung, heart, liver, kidney, neuromuscular, genetic, or severe psychiatric diseases
  • Recent growth of pituitary tumor or other intracranial tumor
  • History of acromegaly
  • Taking medication to suppress appetite or reduce weight, or antidepressant drugs
  • Poorly-controlled high blood pressure or diabetes

Information from the National Library of Medicine

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 identifier (NCT number): NCT00490191

  Show 26 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Layout table for investigator information
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:
Layout table for additonal information Identifier: NCT00490191     History of Changes
Other Study ID Numbers: 2073
First Posted: June 22, 2007    Key Record Dates
Last Update Posted: June 22, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
Layout table for MeSH terms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs