EUCTR2005-002607-17-GB进行中（未招募）1 期
Effect of Transdermal Testosterone Replacement in Hypogonadal Men with either Metabolic Syndrome or Type 2 Diabetes Mellitus - TIMES 2
Prostrakan Pharmaceuticals Ltd0 个研究点目标入组 520 人开始时间: 2005年8月3日最近更新:
适应症
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
- 520
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. Male patients aged at least 40 years old
- •2. An early morning total testosterone level less than or equal to 11 nmol/L or calculated free testosterone levels less than or equal to 255 pmol/L, at least two separate timepoints, (between 08.00 - 10.00), at least one week apart.
- •3. At least two symptoms of hypogonadism (e.g. decreased libido, erectile function, lean body mass or muscle mass; decrease in bone mineral density resulting in osteoporosis; depression, irritability and diminution of mental acuity; fatigue; and vasomotor symptoms, such as hot flushes)
- •4. Metabolic syndrome as defined by the International Diabetes Federation (IDF):
- •Central obesity (defined as a waist circumference greater than or equal to 94 cm for Europid men, with ethnicity specific values for other groups) and any two of the following four factors:
- •(a) raised TG level: greater than or equal to 150 mg/dL (greater than or equal to 1.7 mmol/L), or specific treatment for this lipid abnormality
- •(b) reduced HDL cholesterol: less than 40 mg/dL (less than 1.03 mmol/L in males, or specific treatment for this lipid abnormality
- •(c) raised blood pressure: systolic BP greater than or equal to 130 mmHg or diastolic BP greater than or equal to 85 mmHg, or treatment of previously diagnosed hypertension
- •(d) raised fasting plasma glucose (FPG) greater than or equal to 100 mg/dL (greater than or equal to 5.6 mmol/L), or previously diagnosed type 2 diabetes mellitus. If above 100 mg/dL or 5.6 mmol/L, an oral glucose tolerance test (OGTT) is strongly recommended but is not necessary to define presence of the syndrome.
- •and/or type 2 diabetes mellitus as defined by:
- •fasting plasma glucose (FPG) greater than or equal to 126 mg/dL (greater than or equal to 7.0 mmol/L) on two occasions or random glucose greater than or equal to 200 mg/dL (greater than or equal to 11.1 mmol/L) and classic symptoms of type 2 diabetes mellitus (polyuria, polydipsia, polyphagia, with / without weight loss) or previously diagnosed type 2 diabetes mellitus.
- •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
- •1. Treatment with testosterone replacement therapy within 6 months of randomisation
- •2. Use of any other hormone manipulating therapy, or glucocorticoids and topical steroids (intranasal, inhaled or dermal) within 3 months of randomisation
- •3. Insulin treated patients
- •4. History of, or current prostate carcinoma
- •5. Age-adjusted elevated PSA level
- •6. Abnormal DRE of prostate, suggestive of cancer
- •7. Severe symptomatic benign prostatic hyperplasia
- •8. Patients actively or potentially trying to start a family or requiring fertility treatment
- •9. Clinically significant hepatic, respiratory, haematological (haematocrit not greater than 52% at Baseline) or renal disease
- •10. History of drug or alcohol abuse
- •11. Receiving other trial drugs within 12 weeks
- •12. Symptomatic obstructive sleep apnoea syndrome
- •13. History or presence of male breast cancer
- •14. Hyperprolactinaemia or pituitary tumour
- •15. Any other reason, which the Investigator feels precludes safe inclusion of the patient.
研究者
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