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

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Brief Title

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

Official 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.

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

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

Condition

Growth Hormone Deficiency

Intervention

Blood sample

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

90

Start Date

April 2002

Completion Date

April 2005

Eligibility Criteria

        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

Gender

All

Ages

15 Years - 20 Years

Accepts Healthy Volunteers

No

Contacts

Pfizer CT.gov Call Center, ,

Administrative Informations

NCT ID

NCT00156143

Organization ID

307-MET-9002-016

Secondary IDs

A6281018

Study Sponsor

Pfizer

Study Sponsor

Pfizer CT.gov Call Center, Study Director, Pfizer

Verification Date

July 2007