NCT00490191

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hypopituitarism

Interventions

Type	Name	Description
DRUG	Somatropin

Timeline

• Start date: 1999-01-01
• Completion: 2001-07-01
• First posted: 2007-06-22
• Last updated: 2007-06-22

Locations

26 sites across 6 countries: United States, France, Germany, Italy, Puerto Rico, United Kingdom