Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents

Phase 3

Completed

• Conditions: Growth Hormone Deficiency

• Registration Number: NCT00156143
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study Completion: 2005-04
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-27
• Last Update Posted: 2007-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.