DRKS00003136已完成3 期
Comparison of clinical and metabolic effects of testosterone and estrogens in adult gonadectomized patients with 46,XY DSD due to complete androgen insensitivity syndrome (CAIS) - CAIS-Study
niversitätsklinikum Schleswig-Holstein, Campus Lübeck, kaufmännischer Vorstand0 个研究点目标入组 26 人开始时间: 2011年10月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Female
入选标准
- •Postpubertal adult patient with complete androgen insensitivity syndrome classified as either Sinnecker Type 5A or 5B (1)
- •Mutation of the androgen receptor gene proved
- •Gonadectomy at least 1 year before entering the study
排除标准
- •1. Disorder of Sex Development other than complete androgen insensitivity syndrome
- •2. Steroid medication other than study trial medication
- •3. Gonads in situ
- •4. Disorder of liver function
- •5. Chronic skin disease
- •6. Serious chronic disorders affected by sex steroid medication
- •7. Malignant disorders
- •8. Severe psychiatric disorders
- •9. Porphyria
- •10. previous venous thromboembolism or arterial embolism
- •11. hypersensitivity versus active substance or auxiliary substances of study medication
- •12. participation in other clinical trial in the foregone 4 weeks, individual decision of the principal investigator possible
- •13. any circumstances that arise doubts that the trial is reasonable for the individual patient or circumstances that hinder a protocol conform conduct
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