JPRN-UMIN000000465已完成未知
Double-blind Placebo-controlled Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA) - Phase III Clinical Trial of Leuprorelin acetate in Patients with SBMA (JASMITT)
Center for Clinical Trials, Japan Medical Association0 个研究点目标入组 170 人开始时间: 2006年9月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30years-old 至 70years-old（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •1) Patients who have taken LH-RH agonists, testosterone drugs, 5-alpha-reductase inhibitors, anti-androgen drugs or estrogen drugs within 48 weeks prior to the informed consent. 2) Patients who have taken LH-RH agonists for more than 48 weeks prior to the informed consent. 3) Patients who have undergone operations (eg. orchiectomy), which reduce serum testosterone levels. 4) Patients who are unable to undergo skin biopsies. 5) Patients who are unable to undergo videofluorography. 6) Patients who are diagnosed being depressed by M.I.N.I. Japanese version 5.0.0 major depression episode. 7) Patients who have severe complications. 8) Patients who have suffered angina pectoris or myocardial infarction within one month prior to the informed consent. 9) Heart rate > 120 bpm, systolic BP > 180mmHg or diastolic BP > 100 mmHg. 10) Patients with past medical history of allergy to leuprorelin acetate, synthetic LH-RH or LH-RH delivatives. 11) Patients who have participated in other clinical trials within 12 weeks prior to the informed consent. 12) Patients who are not appropriate to participate to the trial.
研究者
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