A Phase 4 interventional study of Somatropin in Hypopituitarism, sponsored by Eli Lilly and Company. Completed at 26 sites in 6 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2007-06-22.
Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment
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.
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.
47 studies on the registry are indexed under Hypopituitarism; 8 are open to participants now.
This study's enrollment of 387 is above the median of 38 across 29 interventional studies indexed under Hypopituitarism.
Browse Hypopituitarism studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
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Exclusion Criteria:
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Clinically significant
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Percent change in total fat mass
Time frame: Eight months
Safety
Time frame: Eight months
The record gives a start of Jan 1999 and a completion of Jul 2001. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Human Growth Hormone