Hormone Treatment in Growth Hormone and Testosterone Deficient Patients (NCT01397500) | Clinical Trial Compass
TerminatedPhase 2
Hormone Treatment in Growth Hormone and Testosterone Deficient Patients
Stopped: Recruitment problems due to change of patient population at site.
Germany54 participantsStarted 2011-11
Plain-language summary
Growth hormone and gonadotropin deficiency after brain injury (traumatic brain injury, ischemic stroke, subarachnoidal hemorrhage): the effects of hormone replacement on cognition, quality of life and body composition Randomized, controlled, 3 arm (group 2: double-blind; groups 1 and 3: open), multi-center, pilot study (Phase II)
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age
✓. F/M
✓. Stable phase after TBI, SAH or IS
✓. Stable substitution of other hormonal axes
✓. GH below 6 ng/ml after stimulation with ITT or GH below cut-off in GHRH/arginine test using BMI-adjusted cut-off limits, GHRH/arginine test should be done only in patients denying or with a contraindication for ITT
✓. Written informed consent
✓. Age
✓. M
Exclusion criteria
✕. Pregnancy/lactation period
✕. Women of childbearing potential not using an adequate method of birth control
✕. Men not willing to use an adequate method of birth control
✕. Previous or concomitant medication with GH
✕. Hypersensitivity to GH
✕. Drug or alcohol abuse
✕. Condition which in opinion of investigator makes patient unsuitable for inclusion