NCT00858650已完成不适用
Registry of Hypogonadism in Men
Carelon Research25 个研究点 分布在 6 个国家目标入组 999 人开始时间: 2009年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 999
- 试验地点
- 25
- 主要终点
- Prostate Cancer
研究概览
简要总结
The primary objective of the Registry of HYpogonadism in MEn (RHYME) is to establish and maintain a large, multi-national prospective registry of male patients who have been diagnosed with male hypogonadism (HG), also known as androgen deficiency or testosterone deficiency.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 18 years and older.
- •Diagnosis of hypogonadism including Klinefelter's or late onset HG. Patients may have been diagnosed at any point in their lives. Documentation of the diagnosis of HG (including symptomatology and laboratory values including testosterone levels confirmed on two separate occasions) is required.
- •Written informed consent.
排除标准
- •Any previous treatment with testosterone therapy.
- •History of breast cancer, prostate cancer, or high-grade prostatic intraepithelial neoplasia.
- •Prior radical prostatectomy.
- •Life expectancy shorter than 24 months as judged by the Clinical Site investigator.
- •Current major psychiatric disorders or drug or alcohol abuse, which will likely affect participation or compliance in the Registry, in the opinion of the Clinical Site Investigator.
- •Gender dysphoria or sexual reassignment (e.g., transexualism).
- •Patients actively enrolled in any interventional clinical trial.
- •Planned relocation outside Clinical Site region within 24 months.
结局指标
主要结局
Prostate Cancer
时间窗: 2-years
次要结局
- Physical Health and Cardiovascular Outcome Measures(3-years)
- PSA, IPSS, and Other Urologic Outcomes(3-years)
- Sexual Function and Hypogonadism Symptoms(3-years)
研究者
研究点 (25)
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