NCT06466369已完成3 期
Efficacy and Safety of Once Daily Administration Tadalafil in Patients With Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Evaluation of International prostate symptom score (IPSS)/quality of life (QoL).
研究概览
简要总结
The aim of the present study is to evaluate the efficacy and safety of once daily administration PDE5 inhibitors, tadalafil for 3 months as anti-inflammatory, antiproliferative and relaxant effects in ED with BPH patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
double-blinded
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 45 years and sexually active with symptomatic benign prostatic hyperplasia (no hospitalization 3 months prior to start of treatment).
排除标准
- •Patients with bladder or prostate malignancy.
- •A history of lower urinary tract surgery.
- •History of catheterization.
- •Urinary retention.
- •Urinary tract infection.
- •Stone disease.
- •Any neurological disease.
研究组 & 干预措施
Low-dose intervention group
Experimental
干预措施: Tadalafil (Drug)
High-dose intervention group
Experimental
干预措施: Tadalafil (Drug)
结局指标
主要结局
Evaluation of International prostate symptom score (IPSS)/quality of life (QoL).
时间窗: 3 months compared to baseline
Evaluation of International index of erectile function (IIEF).
时间窗: 3 months compared to baseline
次要结局
未报告次要终点
研究者
ahmed salah saad abomandour
Principal Investigator
Al-Azhar University
研究点 (1)
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