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The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly probable adult growth hormone deficiency (AGHD) and subjects who were probably free of AGHD.
Full description
The randomisation was carried out before the first test was performed. In order to be informed of the subject's randomisation group, the investigator phoned the access number given to him/her. The subject's allocation to a given randomisation arm was determined on the basis of a centralised randomisation (answering service), balanced per group of subjects with a minimisation on 2 criteria: age and BMI.
This was a centralised randomisation using a Interactive Voice Response System (IVRS) which was balanced in each of the following 3 categories of subjects:
In each of these 3 categories, the subjects underwent 3 tests whose sequences were determined by the following randomisation group:
Enrollment
Sex
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Volunteers
Inclusion criteria
Subjects aged over 18 years and under 60 years,
Female or male,
Subjects not treated by GH or having stopped the treatment more than 15 days ago,
Effective contraception in women of childbearing age: hormonal contraception or use of female condom and spermicides or use of diaphragm and spermicides or Intra Uterine Device (IUD),
Signed informed consent,
Subjects possessing social security cover.
Subjects having at least one of the following criteria were considered as subjects with a high probability of presenting a GH deficit:
Subjects having at least one of the following criteria were considered as subjects with a low probability of presenting a GH deficit:
The third category of subjects eligible was made of healthy volunteers.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
69 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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