EUCTR2014-005179-10-GR进行中（未招募）1 期
Effect of long-term testosterone replacement therapy on arterial stiffness and endothelial function in male patients with hypogonadism
Charalampos Vlachopoulos0 个研究点目标入组 24 人开始时间: 2015年7月24日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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
入选标准
- •1) Providing written consent prior to effecting any procedure of the study 2)Male patients 35-64 years 3) Diagnosis of hypogonadism. The deficiency of testosterone should be demonstrated by clinical features, as assessed by medical history, clinical examination and ADAM questionnaire (Annex B) and confirmed by two separate measurements of morning blood testosterone [either total testosterone < 350 ng / dL (12 nmol / L) or free testosterone < 8 ng / dL (270 pmol / L)].
- •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 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Participation in the design and conduct of the study 2) Participation in another study in the period between the time of the baseline measurement and evaluation which will take place during the observation period, except for participation in registries or epidemiological studies (surveys) that do not affect hypogonadism therapy 3) Female sex 4) Patients > 64 years old or patients < 35 years old 5) Patients with known cardiovascular disease 6) Androgen dependent prostate cancer or male breast gland 7) History or presence of liver tumors 8) Hypersensitivity to the active substance or to any excipient of injectable long-acting testosterone undecanoate solution 9)PSA > = 4 ng / ml 10) Severe symptoms of lower urinary tract due to benign prostatic hyperplasia 11) Malignancy, autoimmune disease or any other modern illness (eg, neurological or psychiatric illness), which could affect or prevent the study to be completed according to the researcher's view 12) Polycythemia / or hematocrit > 50% 13) Overt endocrine disease e.g. uncontrolled thyroid disorders or disorders of the hypothalamic-pituitary adrenal axis (except diabetes mellitus) 14) Contemporary or recent (last year) use of steroids (anabolic or androgenic), ACTH, 5-alpha reductase inhibitors, 5-phosphodiesterase inhibitors, beta-blockers and drugs that are known to affect the testosterone metabolism 15) Severe renal impairment (GFR < 30 ml / min / 1.73m2) 16) Severe hepatic impairment, defined as liver cirrhosis, increased transaminases (AST or ALT) or alkaline phosphatase more than three times the upper normal limit or hyperbilirubinemia 17) Severe obstructive sleep apnea 18) Infertility or desire for immediate procreation (within 2 years of study entry) 19) Simultaneous use of oral vitamin K antagonists (acenocoumarol, warfarin) 20) Patients with restrictions on the use of intramuscular injections as in patients with acquired or congenital abnormalities of blood coagulation 21) Life expectancy less than 3 years 22) Incompliance with the study protocol e.g. due to scheduled move away from the place of the study or abuse of alcohol or drug use.
研究者
相似试验
招募中
Unknown
Effect of testosterone replacement associated with bariatric surgery in men with obesityObesityRBR-9qks3pcHospital e Maternidade São Domingos
招募中
4 期
Study of effects of testosterone replacement therapy in hypogonadal men with type 2 diabetes mellitusCTRI/2019/09/021175Dr Ronak Gandhi
进行中（未招募）
1 期
The effect of testosterone replacement threapy in men using opioidsEUCTR2014-004729-42-DKOdense University Hospital, department M40
已完成
不适用
Effect of transdermal testosterone replacement in hypogonadal men with decreased insulin sensitivityHypogonadal men with decreased insulin sensitivityNutritional, Metabolic, EndocrineTesticular hypofunctionISRCTN45741714ProStrakan Pharmaceuticals (UK)320
进行中（未招募）
不适用
Effect of Transdermal Testosterone Replacement in Hypogonadal Men with either Metabolic Syndrome or Type 2 Diabetes Mellitus - TIMES 2Male hypogonadism is generally characterised by abnormally low serum testosterone levels. Symptoms include changes in mood, decreased bone mineral density, increased body fat, decreased muscle mass and strength and sexual dysfunction. A number of conditions can also be associated with decreased testosterone production including metabolic syndrome, type II diabetes mellitus, atherosclerosis, myocardial infarction and chronic heart failureEUCTR2005-002607-17-DEProstrakan Pharmaceuticals Ltd520