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 - IHGD/Testo Stud

• Conditions: hormonal deficiency after traumatic brain injury, subarachnoidal hemorrhage and ischemic stroke); MedDRA version: 12.1Level: LLTClassification code 10022466Term: Insufficiency pituitary

• Registration Number: EUCTR2010-020679-21-DE
• Lead Sponsor: Max-Planck-Institut für Psychiatrie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-30
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 68

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 < 6 ng/ml after stimulation with Insuline (ITT) or GH level below the
cut-off in GHRH/arginine test using BMI-adjusted cut-off limits
GHRH/arginine test should be done only in those patients with a
contraindication for ITT (diabetes, uncontrolled seizures, heart pain) or in those
patients who deny consent to ITT.
6)Written informed consent by patient or a legally accepted representative

Study group 2:
1)Adult patients between 18 and 65 years
2)Only males
3)Prostate specific antigen (PSA) in normal range
4)Stable phase after brain injury as judged by the neurologist after TBI , SAH or ischemic stroke before screening
5)Stable substitution of other hormonal axes
6)< 3.5 ng/ml testosterone (< 12.1 nmol/l)
7)Written informed consent by patient or a legally accepted representative

Study group 3:
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)GH level < 6 ng/ml after stimulation with insuline (ITT) or GH level below the
cut-off in GHRH/arginine test using BMI-adjusted cut-off limits
GHRH/arginine test should be done only in those patients with a
contraindication for ITT (diabetes, uncontrolled seizures, heart
pain) or in those patients who deny consent to ITT.
5) Written informed consent by patient or a legally accepted
representative.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified