EUCTR2014-004422-17-IT进行中（未招募）1 期
Double-blinded placebo-controlled study on men with lower urinary tract symptoms secondary to prostatic hyperplasia (LUTS-BPH) to assess changes in pressure flow study (PFS) and in molecular profile of prostatic tissue and to correlate this parameters with modifications of symptoms scores (IPSS) after 12 weeks treatment with tadalafil
IVERSITY OF FLORENCE0 个研究点目标入组 86 人开始时间: 2015年1月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
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
- 性别
- Male
入选标准
- •adult male subjects planned to undergo simple prostatectomy (TURP, Transurethral resection of the prostate, or open prostatectomy) for benign prostatic hyperplasia;
- •treatment with alpha-blockers (Tamsulosin 0.4 mg/die)
- •being capable of giving informed consent.
- •18 Years and older
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •participation in another clinical study;
- •known or suspected presence of prostatic cancer or PSA (prostate specific antigen) value >10 ng/mL;
- •suspected lack of the participant's compliance;
- •known severe allergies or hypersensitivity to the study drug (active substance or excipients of the formulation);
- •nown neurogenic bladder (i.e. Parkinson's disease);
- •suspected or proven urinary infections;
- •presence of bladder stone.
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