Hormone Treatment in Growth Hormone and Testosterone Deficient Patients

NCT ID: NCT01397500

Last Updated: 2016-01-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-03-31

Brief 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)

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.

Conditions

Hormone Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Genotropin

Intervention Type: DRUG

Genotropin administered sc once a day by patient or caregiver.

Testosterone undecannoate

18 weeks testosterone undecanoate/placebo (double-blind treatment) 1000 mg/4 ml at baseline and after 6 weeks

Group Type: ACTIVE_COMPARATOR

Testosterone undecannoate

Intervention Type: DRUG

Testosterone undecannoate administered twice (6 week Interval) im by investigator.

control group

No Intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Genotropin

Genotropin administered sc once a day by patient or caregiver.

Intervention Type: DRUG

Testosterone undecannoate

Testosterone undecannoate administered twice (6 week Interval) im by investigator.

Intervention Type: DRUG

Other Intervention Names

GH; Testo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schoen Clinic Bad Aibling

OTHER

Sponsor Role: collaborator

Max-Planck-Institute of Psychiatry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Sievers, MD

Role: PRINCIPAL_INVESTIGATOR

Max Planck Institute

Locations

Max Planck Institute

Munich, Bavaria, Germany

Countries

Germany

References

Leonhardt M, Kopczak A, Schapers B, Limbrock J, Samann PG, Czisch M, von Steinbuechel N, Jordan M, Schneider HJ, Schneider M, Sievers C, Stalla GK. Low Prevalence of Isolated Growth Hormone Deficiency in Patients After Brain Injury: Results From a Phase II Pilot Study. Front Endocrinol (Lausanne). 2018 Dec 17;9:723. doi: 10.3389/fendo.2018.00723. eCollection 2018.

Reference Type: DERIVED

PMID: 30619080 (View on PubMed)

Other Identifiers

CS/Muenchen 02

Identifier Type: -

Identifier Source: org_study_id