EUCTR2010-020018-27-GB进行中（未招募）1 期
Effect of Testosterone on endothelial function and Microcirculation in Type 2 Diabetic patients with Hypoganadism. - Hypogonadism and Endothelial Dysfunction in Type 2 Diabetes.
Tameside Hospital NHS Foundation Trust0 个研究点目标入组 40 人开始时间: 2012年3月29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
- 40
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
- •i. Type 2 Diabetes as judged by WHO criteria:(i)onset of diabetes mellitus after the age of 30 years (ii) blood glucose controlled by diet or drugs other than insulin, or insulin initiated after 2 years diagnosis of diabetes and (iii)no history of diabetic ketoacidosis. ii. Symptomatic Hypogonadism as defined by: Total testosterone below 10mmol/l Aging males' symptom score (AMS)above 36 iii. Hypogonadic men with or without erectile dysfunction. 1v. Age range 50-80 years v. Patients naive to testosterone treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •i. Patients with uncontrolled hypertension (BP>145/95 on treatment)or significant hypotension. (BP<100 systolic) ii. Current smokers. iii. Recent myocardial infarction (<6 months), unstable angina or ongoing chest pain, recent (within 6 months) cardiac intervention (e.g. angioplasty, stenting or CABG) or stroke. iv. Patients with clinical nephropathy ( 24 hr protein>0.5g or dipstix protein+) or moderate renal failure ( serum creatinine> 150umol/l) v. History of prostate cancer or suspicion of prostate cancer on clinical examination. vi. Androgen dependent carcinoma of the male mammary gland. vii. Liver tumors. viii. Hypersensitivity to NEBIDO or Levitra or any of their incipients. ix. Polycythemia. x. General systemic illness, including cardiac, renal or hepatic insufficiency. xi. Patients on nitrates will not be included in the Levitra arm. xii. History of loss of vision in one eye because of non arteric ischaemic optic neuropathy(NAION), regardlesss of whether this episode was in connection or not with previous PDE5 inhibitor exposure. xiii. Hereditary degenerative retinal disorders such as retinitis pigmentosa. xiv. Clinically significant chronic haematoligical disease which may lead to priapism. xv. Bleeding disorders. xvi. Significant active petic ulceration. xvii. Concomitant use of vardenafil with HIV protease inhibitors such as ritonavir and indinavir is contraindicated, as they are potent inhibitors of CYP 3A4. xviii. Concomitant use of of vardenafil with potent CYP 3A4 inhibitors ketoconazole and itaconazole (oral form) is contra-indicated in men older than 75 years. xix. Patients deemed unable to comply with the requirments of the protocol. xx. Patients who have been on testosterone treatment in the past.
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