Hormone Treatment in Growth Hormone and Testosterone Deficient Patients

Hormone Deficiency Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01397500
• Other study ID #: CS/Muenchen 02
• Status: Terminated
• Phase: Phase 2
• First received: May 17, 2011
• Last updated: January 8, 2016
• Start date: November 2011
• Est. completion date: March 2015

Study information

• Verified date: January 2016
• Source: Max-Planck-Institute of Psychiatry
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hormone Deficiency

Intervention

Drug:
• Genotropin
Genotropin administered sc once a day by patient or caregiver.
• Testosterone undecannoate
Testosterone undecannoate administered twice (6 week Interval) im by investigator.

Locations

Country	Name	City	State
Germany	Max Planck Institute	Muenchen	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Max-Planck-Institute of Psychiatry	Schoen Clinic Bad Aibling

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	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.	6 months	No