Hormone DeficiencyPhase 2NCT01397500
Hormone Treatment in Growth Hormone and Testosterone Deficient Patients
A Phase 2 study testing Genotropin and Testosterone undecannoate in people with Hormone Deficiency, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hormone Deficiency
- What is being tested?
- Genotropin and Testosterone undecannoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Mar 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group 1:
- Age
- F/M
- Stable phase after TBI, SAH or IS
- Stable substitution of other hormonal axes
- 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
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- Written informed consent
- Group 2:
- Age
- M
- PSA in normal range
- Stable phase after TBI, SAH or IS
- Stable substitution of other hormonal axes
- Below 3.5 ng/ml testosterone
- Written informed consent
- Group 3:
- Age
- F/M
- Stable phase after TBI, SAH or IS
- 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
- Written informed consent
Who cannot join
- Group 1:
- Pregnancy/lactation period
- Women of childbearing potential not using an adequate method of birth control
- Men not willing to use an adequate method of birth control
- Previous or concomitant medication with GH
- Hypersensitivity to GH
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- Drug or alcohol abuse
- Condition which in opinion of investigator makes patient unsuitable for inclusion
- Participation in another clinical trial with investigational new drug
- Planned treatment or changes in established treatment with other drug which might significantly influence GH axis or cognitive function
- Non-ability to perform testing
- Presence of other conditions listed in contraindications or warnings in local SPC of GH
- Onset of GH-deficiency before BI
- Group 2:
- Men not willing to use an adequate method of birth control
- Previous or concomitant medication with androgens or anabolic steroids within 12 months
- Hypersensitivity to active substances or excipients of Nebido®
- Drug or alcohol abuse
- Condition which in opinion of investigator makes patient unsuitable for inclusion
- Participation in another clinical trial with investigational new drug
- Planned treatment or changes in established treatment with other drug which might influence gonadotrophic axis or cognitive function
- Severe disturbances in articulation, visual faculty, hearing
- Presence of other conditions listed in contraindications or warnings in local SPC of Nebido®
- Onset of hormonal deficiency before BI
- 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
- Abnormal finding on DRE
- PSA higher 4 ng/ml
- History of clinically significant post void residual urine before BI
- Suspicion or known history of liver tumor
- Blood coagulation irregularities presenting an increased risk of bleeding after i.m injections
- Hypercalcemia accompanying malignant tumors
- Sleep apnea
- Polycythemia
- Haematocrit higher than 50 %
- Concurrent use of DHEA, anabolic steroids, clomipramine, antiandrogens, estrogen, ACTH, corticosteroids, oxyphenbutazone
- Uncontrolled thyroid disorders like diabetes mellitus, epilepsia, migraine, hypertension, coronary heart disease as well as hepatic, renal or cardiac insufficiency
- Patients requiring or undergoing fertility treatment
- Condition which in opinion of investigator makes patient unsuitable for inclusion
- Non-ability to perform cognitive testing
- Onset of androgen deficiency before BI.
- Group 3:
- Previous or concomitant medication with androgens, GH or anabolic steroids within 12 months
- Drug or alcohol abuse
- Condition which in opinion of investigator makes patient unsuitable for inclusion
- Participation in another clinical trial with investigational new drug
- Planned treatment or changes in established treatment with other drug which might influence gonadotrophic axis or cognitive function
- Severe disturbances in articulation, visual faculty, hearing
- Non-ability to perform cognitive testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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
- Being tested
- Genotropin, Testosterone undecannoate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenotropinDrug
Also called GH
Genotropin administered sc once a day by patient or caregiver.
Testosterone undecannoateDrug
Also called Testo
Testosterone undecannoate administered twice (6 week Interval) im by investigator.
| Study group | Role | What they receive |
|---|---|---|
| Genotropin | Active comparator | 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. Receives: Drug: Genotropin |
| Testosterone undecannoate | Active comparator | 18 weeks testosterone undecanoate/placebo (double-blind treatment) 1000 mg/4 ml at baseline and after 6 weeks Receives: Drug: Testosterone undecannoate |
| control group | No intervention | No Intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startNov 2011
- Primary completionFeb 2015
- Study completionMar 2015
Why it stopped: Recruitment problems due to change of patient population at site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max-Planck-Institute of Psychiatry
- Sponsor type
- University, hospital or other
- Collaborators
- Schoen Clinic Bad Aibling
- Responsible party
- Sponsor
- Investigators
- Caroline Sievers, MD, Principal investigator, Max Planck Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397500
- Sponsor's protocol ID
- CS/Muenchen 02
- Status last verified
- Jan 2016
- First submitted
- 17 May 2011
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30619080
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01397500
- Acronym / sponsor ID
- CS/Muenchen 02
- Conditions
- Hormone Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems due to change of patient population at site.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Max-Planck-Institute of PsychiatryUniversity, hospital or other
- Collaborators
- Schoen Clinic Bad Aibling
- Study start
- Nov 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Genotropin | Active comparator | Drug: Genotropin6 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. |
| Testosterone undecannoate | Active comparator | Drug: Testosterone undecannoate18 weeks testosterone undecanoate/placebo (double-blind treatment) 1000 mg/4 ml at baseline and after 6 weeks |
| control group | No intervention | –No Intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age
- F/M
- Stable phase after TBI, SAH or IS
- Stable substitution of other hormonal axes
- 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
Key exclusion criteria (48 listed)
- Pregnancy/lactation period
- Women of childbearing potential not using an adequate method of birth control
- Men not willing to use an adequate method of birth control
- Previous or concomitant medication with GH
- Hypersensitivity to GH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenotropinAlso: GHGenotropin administered sc once a day by patient or caregiver. | Drug | Genotropin |
| Testosterone undecannoateAlso: TestoTestosterone undecannoate administered twice (6 week Interval) im by investigator. | Drug | Testosterone undecannoate |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Recruitment problems due to change of patient population at site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Derived from this study: PubMed 30619080Leonhardt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Sievers, MD principal investigator
Max Planck Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Genotropin and Testosterone undecannoate in people with Hormone Deficiency, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment problems due to change of patient population at site.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01397500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.