Hormone Treatment in Growth Hormone and Testosterone Deficient Patients
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|ClinicalTrials.gov Identifier: NCT01397500|
Recruitment Status : Terminated (Recruitment problems due to change of patient population at site.)
First Posted : July 19, 2011
Last Update Posted : January 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hormone Deficiency||Drug: Genotropin Drug: Testosterone undecannoate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||March 2015|
Active Comparator: Genotropin
6 months Genotropin (open treatment)
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.
Genotropin administered sc once a day by patient or caregiver.
Other Name: 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 Name: Testo
No Intervention: control group
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397500
|Max Planck Institute|
|Muenchen, Bavaria, Germany, 80804|
|Principal Investigator:||Caroline Sievers, MD||Max Planck Institute|