Hormone Treatment in Growth Hormone and Testosterone Deficient Patients

• Status: Terminated
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Max-Planck-Institute of Psychiatry
• Collaborator: Schoen Clinic Bad Aibling
• Treatments: Hormones; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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