EUCTR2005-000027-42-GB进行中（未招募）1 期
The effect of testosterone therapy on angina threshold and atheroma in patients with stable angina - n/a
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •PATIENT SELECTION CRITERIA
- •Patients will be recruited from those under the care of consultant cardiologists
- •within the North Trent network. .
- •Inclusion Criteria.
- •1. Males over 20 years of age
- •2. With stable, chronic angina pectoris for > 1 month
- •3. With S-T segment depression of > 1mm within 12 minutes of the Bruce
- •4. Willing and able to give informed consent and comply with the study
- •5. Serum testosterone (<12nmol/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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria.
- •1. Use of androgen therapy or anabolic steroids within 6 months of entry into
- •the study (i.e. screening visit/visit 1) or concurrent use of androgens including
- •dehydroepiandrosterone (DHEA), anabolic steroids, clomipramine, antiandrogens,
- •estrogen, cytochrome P450 inducing medicines (e.g. quinidine, ketoconazole,
- •macrolides), corticotrophins (ACTH), oxyphenbutazone
- •2. Contraindication to treatment with Nebido®.
- •3. Organic hypothalamic-pituitary pathology
- •4. Prostate specific antigen (PSA) ≥4ng/ml
- •5. Severe symptomatic benign prostatic hyperplasia
- •6. Patients actively or potentially trying to start a family or requiring fertility
- •7. Suspicion of, current, or past history of breast or prostatic carcinoma
- •8. MI, CABG or PTCA in the last three months
- •9. Significant hepatic, respiratory, haematological or renal disease
- •10.Haematocrit >50% at entry to the study (i.e. screening visit/visit 1)
- •11.History of significant arrhythmia, WPW syndrome, or >1st degree heart block.
- •CVA within the last three months
- •12. History of drug or alcohol abuse
- •13. Receiving other trial drugs within 12 weeks
- •14. Hypotension (systolic BP< 100 mm Hg)
- •15. Severe, malignant, complicated, renovascular, secondary, or uncontrolled
- •hypertension (BP>180/114)
- •16. Hypercalcaemia
- •17. Nephrotic range proteinuria
- •18. Symptomatic obstructive sleep apnoea syndrome
- •19. With ECG abnormalities that preclude ST segment analysis (eg LBBB, AF)
研究者
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