CTRI/2013/12/004252招募中未知
A Study to Evaluate the Prevalence of Hypogonadism in Indian Males with Type 2 Diabetes Mellitus (DM).
MSD Pharmaceuticals Pvt Ltd0 个研究点目标入组 897 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 897
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Males between the age of 30 to 59 years (both inclusive), with a confirmed diagnosis of Type-2 diabetes mellitus
- •2.Each subject must be willing to provide written informed consent
排除标准
- •1.Type 1 diabetes patients
- •2.Patients receiving testosterone replacement therapy
- •3.Patients suffering from any chronic liver disease, renal disease, advanced malignancy, debilitating diseases like tuberculosis, malabsorption, inflammatory bowel disease, pyrexia of unknown origin, AIDS, sickle cell disease, autoimmune diseases like rheumatoid arthritis, ankylosing spondylitis
- •4.Patients with known causes of hypogonadism including:
- •o Hypergonadotropic hypogonadism or primary hypogonadism: testicular failure due to genetic disorders (e.g., Klinefelterâ??s syndrome), orchitis, trauma, castration, radiation, chemotherapy, or undescended testes
- •o Hypogonadotropic hypogonadism, central hypogonadism, or secondary hypogonadism: patients with gonadotropin deficiency or dysfunction as a result of disease or damage to the hypothalamic-pituitary axis (e.g. Kallmannâ??s syndrome, tumour, trauma, radiation, sarcoidosis, or tuberculosis).
- •5.Patients on medications, or have taken medications in last 6 months, known to cause hypogonadal states like ketoconazole, anabolic steroids, corticosteroids, spironolactone, cimetidine, phenytoin, GnRH analogue, flutamide and narcotic addicts (heroin).
- •6.Patients having severe psychological symptoms
- •7.Patients currently enrolled in another clinical trial
- •8.Patients having any clinically significant condition or situation, other than the condition being studied that, in the opinion of the Investigator, would interfere with the study evaluations or optimal participation in the study.
研究者
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