EUCTR2010-020679-21-DE进行中（未招募）不适用
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 - IHGD/Testo Stud
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Study group 1:
- •1)Adult patients between 18 and 65 years
- •2)Female and male
- •3)Stable phase after brain injury as judged by the neurologist after TBI, SAH or
- •ischemic stroke before screening
- •4)Stable substitution of other hormonal axes
- •5)GH level < 6 ng/ml after stimulation with Insuline (ITT) or GH level below the
- •cut-off in GHRH/arginine test using BMI-adjusted cut-off limits
- •GHRH/arginine test should be done only in those patients with a
- •contraindication for ITT (diabetes, uncontrolled seizures, heart pain) or in those
- •patients who deny consent to ITT.
- •6)Written informed consent by patient or a legally accepted representative
- •Study group 2:
- •1)Adult patients between 18 and 65 years
- •2)Only males
- •3)Prostate specific antigen (PSA) in normal range
- •4)Stable phase after brain injury as judged by the neurologist after TBI , SAH or ischemic stroke before screening
- •5)Stable substitution of other hormonal axes
- •6)< 3.5 ng/ml testosterone (< 12.1 nmol/l)
- •7)Written informed consent by patient or a legally accepted representative
- •Study group 3:
- •1)Adult patients between 18 and 65 years
- •2)Female and male
- •3)Stable phase after brain injury as judged by the neurologist after TBI, SAH or
- •ischemic stroke before screening
- •4)GH level < 6 ng/ml after stimulation with insuline (ITT) or GH level below the
- •cut-off in GHRH/arginine test using BMI-adjusted cut-off limits
- •GHRH/arginine test should be done only in those patients with a
- •contraindication for ITT (diabetes, uncontrolled seizures, heart
- •pain) or in those patients who deny consent to ITT.
- •5) Written informed consent by patient or a legally accepted
- •representative.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Study group 1 (GH-group)
- •1.Pregnancy and lactation period (not applicable for male patients)
- •2.Women of childbearing potential not using an adequate method of birth control
- •(oral contraceptives and hormonal implants are not allowed).
- •3.Men who are not willing to use an adequate method of birth control
- •4.Previous or concomitant medication with GH
- •5.Suspected or known hypersensitivity to GH
- •6.Suspected or known drug or alcohol abuse
- •7.Any condition which in the opinion of the investigator makes the patient
- •unsuitable for inclusion
- •8.Participation in another clinical trial with an investigational new drug
- •9.Planned treatment or changes in established treatment with any other drug
- •which might significantly influence the GH axis or the cognitive function (e.g.
- •antidepressive treatment)
- •10.Non-abiltiy to perform testing
- •11.Presence of any other conditions listed in the contraindications or warnings in the
- •local SPC of GH
- •12.Onset of GH-deficiency before brain injury
- •Study group 2 (testosterone/placebo group)
- •1.Men who are not willing to use an adequate method of birth control
- •2.Previous or concomitant medication with androgens or anabolic steroids within 12
- •months of entry into the trial
- •3.Suspected or known hypersensitivity to to the active substances or any of the
- •excipients of Nebido® e.g. benzylbenzoate and castor oil
- •4.Suspected or known drug or alcohol abuse
- •5.Any condition which in the opinion of the investigator makes the patient
- •unsuitable for inclusion
- •6.Participation in another clinical trial with an investigational new drug
- •7.Planned treatment or changes in established treatment with any other drug which
- •might influence the gonadotrophic axis or the cognitive function (e.g.
- •antidepressive treatment)
- •8.Severe disturbances in articulation, visual faculty or hearing
- •9.Presence of any other conditions listed in the contraindications or warnings in the l ocal SPC of testosterone (Nebido®)
- •10.Onset of hormonal deficiency before brain injury
- •11.Suspicion or known history of prostate or breast cancer or other hormone
- •dependend neoplasia as well as history of malignancy within the last 5 years
- •12.Abnormal finding on Digital Rectal Examination (DRE)
- •13.Prostate specific antigen (PSA) level upper 4 ng/ml
- •14.History of clinically significant post void residual urine (more than 150 ml) before
- •brain injury
- •15.Suspicion or known history of liver tumor
- •16.Blood coagulation irregularities presenting an increased risk of bleeding after
- •intramuscular injections including vitamin-K-antagonists or other strong
- •anticoagulants
- •17.Hypercalcemia accompanying malignant tumors
- •18.Diagnosed sleep apnea
- •19.Polycythemia
- •20.Haematocrit level ? 50 % at entry to the study
- •21.Concurrent use of dehydroepiandrosterone (DHEA), anabolic steroids,
- •clomipramine, antiandrogens, estrogen, corticotrophics/ACTH, corticosteroids,
- 另有 7 项未显示
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