NCT01397500

Hormone Treatment in Growth Hormone and Testosterone Deficient Patients

Growth Hormone and Gonadotropin Deficiency After Brain Injury (Traumatic Brain Injury, Subarachnoidal Hemorrhage, Ischemic Stroke): the Effects of Hormone Replacement on Cognition, Quality of Life and Body Composition

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Max-Planck-Institute of Psychiatry · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Detailed description

The aim of the study is to investigate the influence of growth-hormone replacement on cognition, quality of life, body mass index, body composition and reorganization of brain activity of hypopituitary patients in a stable, chronic phase after brain injury compared to control patients and the influence of testosterone replacement in gonadotropin deficient patients compared to placebo treated control patients.

Conditions

• Hormone Deficiency

Interventions

Type	Name	Description
DRUG	Genotropin	Genotropin administered sc once a day by patient or caregiver.
DRUG	Testosterone undecannoate	Testosterone undecannoate administered twice (6 week Interval) im by investigator.

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-02-01
• Completion: 2015-03-01
• First posted: 2011-07-19
• Last updated: 2016-01-11

Locations

1 site across 1 country: Germany