EUCTR2006-003101-53-SE进行中（未招募）1 期
A randomised placebo controlled study of transdermal testosterone therapy (testosterone 1% hydroalcohol gel) to investigate the efficacy and safety in men with abdominal obesity, low testosterone levels and early stages of the metabolic cluster syndrome. - ARTinMMS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 176
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. Male 30 to 70 years (inclusive)
- •2. Metabolic syndrome defined according to the International Diabetes Foundation
- •a) Abdominal obesity (waist circumference > 94 cm for European men) and any two of the following criteria
- •b) Triglycerides > 1.7 mmol/L or specific treatment for this
- •c) HDL < 1.03 nmol/L or specific therapy for this
- •d) Systolic blood pressure = 130 mmHg or diastolic BP = 85 mmHg or treatment for this
- •e) Fasting plasma glucose = 5.6 mmol/L
- •or previously diagnosed type 2 diabetes mellitus defined by:
- •Fasting plasma glucose = 7.8 mmol/L on two occasions, or random glucose = 11.1 mmol/L and classic symptoms of type 2 diabetes
- •3.Impaired glucose tolerance
- •If the definition of the metabolic syndrome, as described above, is fulfilled but fasting plasma glucose < 5.6 mmol/L the result of an oral glucose tolerance test must be classified as reduced glucose tolerance with a venous blood glucose 7.8 - 11.1 mmol/L or higher 120 min after intake of 75 g of glucose in a water solution (2h OGTT) (www.diabetes.org/main/info/pre-diabetes.jsp)
- •4.Hypogonadism, S-Testosterone <= 12 nmol/L taken at 8:00-10:00 a.m. and less than 2 months before inclusion in the study.
- •5.Screening value of HbA1c <8.0 %
- •6.Weight below and inclusive 120 kg
- •7.Body Mass Index (BMI) below and inclusive 40
- •8.Hematocrit below and inclusive 50%
- •9.Signed Written informed consent obtained
- •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.Insulin therapy and therapy with glitazones.
- •2.Use of androgen therapy or anabolic steroids within 6 months of entry into the study.
- •3.Known congestive heart failure, progressing angina pectoris or a history of myocardial infarction within the last 12 months.
- •4.Known untreated pituitary disease.
- •5.A history of significant renal or liver disease or any malignancy.
- •6.Any disease requiring long-term use of drugs interfering with androgens; spironolactone, Ketoconazol, corticosteroids, cimetidin, fentiazines, tricyclic antidepressives, anabolic steroids, 5-alfa reductase inhibitors, antiestrogens.
- •7.Prostate Specific Antigen (PSA) >= 4 ng/ml.
- •8.Suspected malignancy after prostata palpation, unless biopsy shows the opposite.
- •9.Malignant tumour of the mammary gland
- •10.Ongoing micturition problem severely affecting patient’s daily living at the discretion of the investigators judged by the investigator.
- •11.Any contraindication for treatment with testosterone 1% hydroalchol gel according to the labelling as well as known or suspected allergy to the specific product used in the study.
- •12.Contagious blood disease.
- •13.Known alcohol or drug abuse, or any condition associated with poor compliance.
- •14.Participation in a clinical study during the last 90 days before start of treatment.
- •15.Previous enrolment or randomisation in the present study.
研究者
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A randomised placebo controlled study of transdermal testosterone therapy (testosterone 1% hydroalcohol gel) to investigate the efficacy and safety in men with abdominal obesity, low testosterone levels and early stages of the metabolic cluster syndrome. - ARTinMMSEUCTR2006-003101-53-DEKarolinska Institutet176
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