EUCTR2009-017139-16-DE进行中（未招募）不适用
Effect of exercise alone or in combination with testosterone replacement on muscle strength and quality of life in older men with low testosterone concentrations: a randomized double-blind, placebo controlled study
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
- 60
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
- Male
入选标准
- •1. Men aged 60 years and older (>60yrs), untrained
- •2. Symptomatic hypogonadism as defined by i and iii:
- •i Total testosterone below 12nmol/l (two tests taken on two different
- •days, measurement 7.00-11.00 a.m.)
- •ii Symptoms of testosterone deficiency recorded in the medical history at
- •ii Total Aging Males’ Symptom score above 36
- •3. Willing to avoid significant change in the pattern of physical exercise and
- •lifestyle for the duration of the study
- •4. Residence in Cologne Area
- •5. Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •1.Previous assignment to treatment during this study
- •2.Use of androgen therapy or anabolic steroids within 12 months of
- •entry into the study (i.e. screening visit/visit 1)
- •3.Current participation in an exercise program or within the last 6 months
- •4.Suspicion or known history of prostate or breast cancer or other hormone
- •dependent neoplasia
- •5.Abnormal finding on Digital Rectal Examination (DRE)
- •6.Prostate specific antigen (PSA) level =4ng/ml
- •7.History of clinically significant post void residual urine (> 150ml)
- •8.Suspicion or known history of liver tumor
- •9.Hypersensitivity to the active substances or any of the excipients of
- •NEBIDO e.g. benzyl-benzoate and castor oil
- •10.Blood coagulation irregularities presenting an increased risk of bleeding
- •after intramuscular injections including vitamin-K-antagonists or other
- •strong anticoagulants
- •11.Hypercalcemia accompanying malignant tumors
- •12.Diagnosed sleep apnea
- •13.Polycythemia
- •14.Hematocrit level >50% at entry to the study (i.e. screening visit/visit 1)
- •15.Use of 5-a-reductase inhibitors (finasteride, dutasteride)
- •16.Prolactin level >25ng/ml
- •17.Organic hypothalamic-pituitary pathology
- •18.Concurrent use of: androgens including dehydroepiandrosterone (DHEA),
- •anabolic steroids, clomipramine, antiandrogens, estrogen, corticotrophins
- •(ACTH), corticosteroids, oxyphenbutazone, growth hormone
- •19.Body mass index >35kg/m2
- •20.Uncontrolled thyroid disorders
- •21.Uncontrolled diabetes mellitus (HbA1c > 9%)
- •22.Epilepsy not adequately controlled by treatment
- •23.Migraine not adequately controlled by treatment
- •24.Patients requiring or undergoing fertility treatment
- •25.Any clinically significant chronic disease that might, in the opinion of the
- •investigator, compromise patient’s safety, interfere with the evaluations,
- •or preclude completion of the trial (e.g. hemochromatosis, chronic lung
- •disease, chronic malabsorption disease)
- •26.Known history of alcohol or drug / substance abuse
- •27.Any medical, psychiatric or other conditions that compromise the patient’s
- •ability to understand the patient information, to give informed consent, to
- •comply with the trial protocol, to understand the questionnaires, to follow
- •the training instructions or to complete the study (e.g.: illiterate; severe
- •visual impairment, severe hearing imparment in the opinion of the
- •investigator).
- •28.Patients under legal protection
- •29.Hypertension which is not adequately controlled
- •30.Heart failure (NYHA II-IV)
- •31.Severe hepatic or severe renal insufficiency in the opinion of the
- •investigator
- •32.Cardiopulmonary disease (Myocardial infarction, angina pectoris),
- •Coronary heart disease not stabilized by therapy (unstable angina
- •pectoris, severe cardiac dysrhythmia/arrhythmia), chronic obstructive
- 另有 5 项未显示
研究者
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