Hormone Treatment in Growth Hormone and Testosterone Deficient Patients

NCT01397500 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-01-11

No results posted yet for this study

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)

Conditions

  • Hormone Deficiency

Interventions

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.

Sponsors & Collaborators

  • Schoen Clinic Bad Aibling

    collaborator OTHER
  • Max-Planck-Institute of Psychiatry

    lead OTHER

Principal Investigators

  • Caroline Sievers, MD · Max Planck Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-02-28
Completion
2015-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01397500 on ClinicalTrials.gov