hormonal deficiency after traumatic brain injury, subarachnoidal hemorrhage and ischemic stroke) MedDRA version: 12.1 Level: LLT Classification code 10022466 Term: Insufficiency pituitary
Conditions
Interventions
Trade Name: Genotropin 5 mg/ml
Product Name: Genotropin 5 mg/ml
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629-01-5
Current Sponso
Sponsors
Max-Planck-Institut für Psychiatrie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study group 1: 1) Adult patients between 18 and 65 years 2) Female and male 3) Stable phase after brain injury as judged by the neurologist after TBI, SAH or ischemic stroke before screening 4) Stable substitution of other hormonal axes 5) GH level =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Study group 1 (GH-group) 1. Pregnancy and lactation period (not applicable for male patients) 2. Women of childbearing potential not using an adequate method of birth control (oral contraceptives and hormonal implants are not allowed). 3. Men who are not willing to use an adequate method of birth control 4. Previous or concomitant medication with GH 5. Suspected or known hypersensitivity to GH 6. Suspected or known drug or alcohol abuse 7. Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion 8. Participation in another clinical trial with an investigational new drug 9. Planned treatment or changes in established treatment with any other drug which might significantly influence the GH axis or the cognitive function (e.g. antidepressive treatment) 10. Non-abiltiy to perform testing 11. Presence of any other conditions listed in the contraindications or warnings in the local SPC of GH 12. Onset of GH-deficiency before brain injury Study group 2 (testosterone/placebo group) 1. Men who are not willing to use an adequate method of birth control 2. Previous or concomitant medication with androgens or anabolic steroids within 12 months of entry into the trial 3. Suspected or known hypersensitivity to to the active substances or any of the excipients of Nebido® e.g. benzylbenzoate and castor oil 4. Suspected or known drug or alcohol abuse 5. Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion 6. Participation in another clinical trial with an investigational new drug 7. Planned treatment or changes in established treatment with any other drug which might influence the gonadotrophic axis or the cognitive function (e.g. antidepressive treatment) 8. Severe disturbances in articulation, visual faculty or hearing 9. Presence of any other conditions listed in the contraindications or warnings in the l ocal SPC of testosterone (Nebido®) 10. Onset of hormonal deficiency before brain injury 11. Suspicion or known history of prostate or breast cancer or other hormone dependend neoplasia as well as history of malignancy within the last 5 years 12. Abnormal finding on Digital Rectal Examination (DRE) 13. Prostate specific antigen (PSA) level upper 4 ng/ml 14. History of clinically significant post void residual urine (more than 150 ml) before brain injury 15. Suspicion or known history of liver tumor 16. Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injections including vitamin-K-antagonists or other strong anticoagulants 17. Hypercalcemia accompanying malignant tumors 18. Diagnosed sleep apnea 19. Polycythemia 20. Haematocrit level ? 50 % at entry to the study 21. Concurrent use of dehydroepiandrosterone (DHEA), anabolic steroids, clomipramine, antiandrogens, estrogen, corticotrophics/ACTH, corticosteroids, oxyphenbutazone 22. Uncontrolled thyroid disoders like diabetes mellitus (HbA1c ? 9 %) epilepsia, migraine, hypertension, coronary heart disease as well as hepatic, renal or cardiac insufficiency 23. Patients requiring or undergoing fertility treatment 24. Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion e.g. chronic lung disease, chronic malabsorption disease 25.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate changes in QoL a) in patients with GH-treatment for 6 months before and after treatment and in comparison to control patients and b) in patients with testosterone-replacement for 18 weeks before and after treatment and in comparison to patients receiving placebo. ;Secondary Objective: To evaluate differences (?) in cognitve function in patients with GH-treatment after 6 months compared to untreated control patients. To evaluate differences (?) in cognitive function in patients with testosterone-treatment for 18 weeks compared to patients receiving placebo or 6 months GH-treatment. To evaluate differences (?) in body composition in patients with GH-treatment after 6 months compared to control patients. To evaluate differences (?) in body composition in patients with testosterone-treatment for 18 weeks compared to patients receiving placebo or receiving 6 months GH-treatment. To evaluate changes in degree of reorganization of brain activity in control patients and in patients with and without GH treatment after 6 months. ;Primary end point(s): Changes (?) in score of SF-12, QoL-AGHDA, EQ-5 D, BDI, PSQI, QOLIBRI | — |
Countries
Germany
Outcome results
None listed