Growth Hormone Deficiency Clinical Trial
— TAUBEROfficial title:
GH Therapy in Partial GHD Adolescents : Evaluation of Efficacy Based on Body Composition and Comparison of 2 Different Doses of Genotonorm®. Open-Label, Randomised, Comparative, Controlled, Parallel-Group, Multi-Center Phase IIIB Clinical Trial.
To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.
Status | Completed |
Enrollment | 90 |
Est. completion date | April 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 20 Years |
Eligibility |
Inclusion Criteria: - Males or females : Chronological age > or = 15 years and < or = 20 years for females - Chronological age > or = 17 years and < or = 20 years for males - GHD of childhood onset treated for at least 2 years - Last GH injection at least 12 months before baseline visit Exclusion Criteria: - Turner's syndrome - Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT > 2 X ULN |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment. |
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