Hormone Treatment in Growth Hormone and Testosterone Deficient Patients

This study has been terminated.
(Recruitment problems due to change of patient population at site.)
Sponsor:
Collaborator:
Schoen Clinic Bad Aibling
Information provided by (Responsible Party):
Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier:
NCT01397500
First received: May 17, 2011
Last updated: January 8, 2016
Last verified: January 2016
  Purpose
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)

Condition Intervention Phase
Hormone Deficiency
Drug: Genotropin
Drug: Testosterone undecannoate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Max-Planck-Institute of Psychiatry:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Quality of Life (QoL) was measured with the following questionnaires prior to treatment and after treatment:

    • SF-12 short-form health questionnaire (12 items, score: min. 12/max. 47)
    • QoL-AGHDA Assessment of GHD in Adults (25 items: yes/no answers)
    • EQ-5 D Euroquol (5 items, scale per items from 1 (no problems) to 3 (severe problems); 1 Likert scale (0 worst-100 best) to measure health status)
    • BDI Beck Depression Inventory (21 items, score: min. 0/max. 63)
    • PSQI Pittsburgh Sleep Quality Index: (4 items regarding sleep duration, 11 items regarding sleep quality, 1 item regarding sleeping medication, 2 item regarding daytime dysfunction, 1 item regarding sleeping habit; 5 items for third-party assessment)
    • QOLIBRI Quality of Life after Brain Injury (37 items, scale per item from 1 (not at all) to 5 (very much) QoL was measured with difference between mean scores of the respective questionnaires, determined before and after treatment.


Enrollment: 54
Study Start Date: November 2011
Study Completion Date: March 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Genotropin

6 months Genotropin (open treatment)

Daily dose:

Male < 45 years: 0,4 mg; ≥ 45 years: 0,2 mg Female < 45 years: 0,5 mg; ≥ 45 years: 0,3 mg Starting with half of the dose for the first 4 weeks.

Drug: Genotropin
Genotropin administered sc once a day by patient or caregiver.
Other Name: GH
Active Comparator: Testosterone undecannoate
18 weeks testosterone undecanoate/placebo (double-blind treatment) 1000 mg/4 ml at baseline and after 6 weeks
Drug: Testosterone undecannoate
Testosterone undecannoate administered twice (6 week Interval) im by investigator.
Other Name: Testo
No Intervention: control group
No Intervention.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Group 1:

  1. Age
  2. F/M
  3. Stable phase after TBI, SAH or IS
  4. Stable substitution of other hormonal axes
  5. 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
  6. Written informed consent

Group 2:

  1. Age
  2. M
  3. PSA in normal range
  4. Stable phase after TBI, SAH or IS
  5. Stable substitution of other hormonal axes
  6. Below 3.5 ng/ml testosterone
  7. Written informed consent

Group 3:

  1. Age
  2. F/M
  3. Stable phase after TBI, SAH or IS
  4. GH higher 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
  5. Written informed consent

Exclusion Criteria:

Group 1:

  1. Pregnancy/lactation period
  2. Women of childbearing potential not using an adequate method of birth control
  3. Men not willing to use an adequate method of birth control
  4. Previous or concomitant medication with GH
  5. Hypersensitivity to GH
  6. Drug or alcohol abuse
  7. Condition which in opinion of investigator makes patient unsuitable for inclusion
  8. Participation in another clinical trial with investigational new drug
  9. Planned treatment or changes in established treatment with other drug which might significantly influence GH axis or cognitive function
  10. Non-ability to perform testing
  11. Presence of other conditions listed in contraindications or warnings in local SPC of GH
  12. Onset of GH-deficiency before BI

Group 2:

  1. Men not willing to use an adequate method of birth control
  2. Previous or concomitant medication with androgens or anabolic steroids within 12 months
  3. Hypersensitivity to active substances or excipients of Nebido®
  4. Drug or alcohol abuse
  5. Condition which in opinion of investigator makes patient unsuitable for inclusion
  6. Participation in another clinical trial with investigational new drug
  7. Planned treatment or changes in established treatment with other drug which might influence gonadotrophic axis or cognitive function
  8. Severe disturbances in articulation, visual faculty, hearing
  9. Presence of other conditions listed in contraindications or warnings in local SPC of Nebido®
  10. Onset of hormonal deficiency before BI
  11. Suspicion or known history of prostate or breast cancer or other hormone dependent neo plasia as well as history of malignancy within last 5 years
  12. Abnormal finding on DRE
  13. PSA higher 4 ng/ml
  14. History of clinically significant post void residual urine before BI
  15. Suspicion or known history of liver tumor
  16. Blood coagulation irregularities presenting an increased risk of bleeding after i.m injections
  17. Hypercalcemia accompanying malignant tumors
  18. Sleep apnea
  19. Polycythemia
  20. Haematocrit higher than 50 %
  21. Concurrent use of DHEA, anabolic steroids, clomipramine, antiandrogens, estrogen, ACTH, corticosteroids, oxyphenbutazone
  22. Uncontrolled thyroid disorders like diabetes mellitus, epilepsia, migraine, hypertension, coronary heart disease as well as hepatic, renal or cardiac insufficiency
  23. Patients requiring or undergoing fertility treatment
  24. Condition which in opinion of investigator makes patient unsuitable for inclusion
  25. Non-ability to perform cognitive testing
  26. Onset of androgen deficiency before BI.

Group 3:

  1. Previous or concomitant medication with androgens, GH or anabolic steroids within 12 months
  2. Drug or alcohol abuse
  3. Condition which in opinion of investigator makes patient unsuitable for inclusion
  4. Participation in another clinical trial with investigational new drug
  5. Planned treatment or changes in established treatment with other drug which might influence gonadotrophic axis or cognitive function
  6. Severe disturbances in articulation, visual faculty, hearing
  7. Non-ability to perform cognitive testing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397500

Locations
Germany
Max Planck Institute
Muenchen, Bavaria, Germany, 80804
Sponsors and Collaborators
Max-Planck-Institute of Psychiatry
Schoen Clinic Bad Aibling
Investigators
Principal Investigator: Caroline Sievers, MD Max Planck Institute
  More Information

No publications provided

Responsible Party: Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier: NCT01397500     History of Changes
Other Study ID Numbers: CS/Muenchen 02 
Study First Received: May 17, 2011
Last Updated: January 8, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2016