Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone Deficiency
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|ClinicalTrials.gov Identifier: NCT00490191|
Recruitment Status : Completed
First Posted : June 22, 2007
Last Update Posted : June 22, 2007
|Condition or disease||Intervention/treatment||Phase|
|Hypopituitarism||Drug: Somatropin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||387 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
- Percent change in total fat mass [ Time Frame: Eight months ]
- Safety [ Time Frame: Eight months ]
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): NCT00490191
Show 26 Study Locations
|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|