ACTRN12614000604606已完成2 期
An Open-Label Study to Characterize the Pharmacokinetics, Effectiveness, and Safety of Subcutaneous Implantation of 12 Testosterone Pellets (AA3000 75mg) in Hypogonadal Males
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- Male
入选标准
- •2. Serum testosterone level of less than 300ng/dL
- •3. Body mass index between 20 and 40
- •4. Be in good general health otherwise
- •5. Able to complete questionnaires
排除标准
- •1. History of allergy or hypersensitivity to the study medication
- •2. History of alcoholism or substance abuse
- •3. History of chronic use of medications such as glucocorticoids
- •4. Previous use or planned use during the study of testosterone products (long acting depot products within 6 months, short acting injectables within 6 weeks, topical or oral products within 14 days before the screening visit)
- •5. Use of medications that may interfere with androgen metabolism (e.g. spironolactone, cimetidine, 5a-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products) within 4 weeks of screening visit or plans to use these during the study.
- •6. History of myocardial infarction, unstable angina, heart failure including congestive heart failure, or ventricular dysrhythmia
- •7. History of venous thromboembolic disease (eg, deep vein thrombosis or pulmonary embolism).
- •8. Uncontrolled hypertension
- •9. Uncontrolled diabetes
- •10. Significant cerebrovascular disease
- •11. History of HIV
- •12. History of polycythemia or erythyrocytosis
- •13. Prostate cancer or a history of prostate cancer
- •14. Serum prostate specific antigen (PSA) level greater than or equal to 4 ng/mL
- •15. Breast cancer
- •16. Liver disease
- •17. Hyperparathyroidism
- •18. Received investigational drug within 30 days before screening visit.
研究者
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