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

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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00156143
Acronym
TAUBER
Enrollment
90
Registered
2005-09-12
Start date
2002-04-30
Completion date
2005-04-30
Last updated
2007-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency

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.

Interventions

PROCEDUREBlood sample
PROCEDURERadiography

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 20 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026