Hormone Treatment in Growth Hormone and Testosterone Deficient Patients

January 8, 2016 updated by: Max-Planck-Institute of Psychiatry

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

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Muenchen, Bavaria, Germany, 80804
        • Max Planck Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: Genotropin
Genotropin administered sc once a day by patient or caregiver.
Other Names:
  • GH
Active Comparator: Testosterone undecannoate
18 weeks testosterone undecanoate/placebo (double-blind treatment) 1000 mg/4 ml at baseline and after 6 weeks
Drug: Testosterone undecannoate
Testosterone undecannoate administered twice (6 week Interval) im by investigator.
Other Names:
  • Testo
No Intervention: control group
No Intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Max-Planck-Institute of Psychiatry

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Schoen Clinic Bad Aibling

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Caroline Sievers, MD, Max Planck Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CS/Muenchen 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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