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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00187993
Date of registration: 12/09/2005
Prospective Registration: No
Primary sponsor: University Hospital, Angers
Public title: Growth Hormone Treatment of Young Growth Hormone-Deficient Adults
Scientific title: Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.
Date of first enrolment: May 2005
Target sample size: 30
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00187993
Study type:  Observational
Study design:  Observational Model: Defined Population, Time Perspective: Longitudinal  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Rohmer Vincent, Professor
Address: 
Telephone:
Email:
Affiliation:  CHU of Angers
Key inclusion & exclusion criteria

Inclusion Criteria:

- Adults (age > 18-35 years)

- Stable body mass +/- 5 kg in 3 months

- GH deficiency since childhood, treated by GH during childhood, having stopped GH
treatment at the end of adolescence

- Want to receive again GH treatment or refusing new GH treatment

- GH deficiency confirmed at adulthood by GHRH-Arginine test

- Women receiving GH treatment must have a efficient contraceptive method

- Have given a writing informed consent

Exclusion Criteria:

- Somatotropic insufficiency

- All pathologies or treatment modifing energetic metabolism, excepted diabet mellitus
and obesity

- Participating to another clinical trial during the three months befor inclusion

- Pathologies modifing bone metabolism

- Pregnancy/Feeding

- Refusal to consent



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Growth Hormone Deficiency
Intervention(s)
Drug: Growth hormone
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
0673 (AFSSAPS)
2004/10 (CCPPRB)
CP-04-03
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Novo Nordisk A/S
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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