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

• Status: Completed
• Trial end date: 2001-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Hormones

Criteria

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