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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Written informed consent
- •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
- •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
排除标准
- •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
- •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
- •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.
- •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
研究组 & 干预措施
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.
干预措施: Genotropin (Drug)
Testosterone undecannoate
18 weeks testosterone undecanoate/placebo (double-blind treatment) 1000 mg/4 ml at baseline and after 6 weeks
干预措施: Testosterone undecannoate (Drug)
结局指标
主要结局
Quality of Life
时间窗: 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.
次要结局
未报告次要终点