NCT00401661已完成4 期
Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL 10mg OD), Open, 24-week Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- MSHQ Ejaculation score
研究概览
简要总结
Primary objective:
- End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD.
Secondary objectives:
- MSHQ-EjD improvement by visit
- Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit
- Onset of action of XATRAL 10mg OD
- Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Alfuzosin for 24 weeks
干预措施: Alfuzosin (Drug)
结局指标
主要结局
MSHQ Ejaculation score
时间窗: End of treatment
次要结局
- IPSS: voiding sub-score(End of treatment)
- MSHQ Ejaculation score(After 12 weeks of treatment)
- Acute Urinary Retention(End of treatment)
- Correlation between MSHQ and IPSS(End of treatment)
- I-PSS total score(End of treatment)
- IPSS total score decrease = 3 points(End of treatment)
- IPSS: filling sub-score(End of treatment)
- IPSS: nocturia symptoms sub-score(End of treatment)
- MSHQ ejaculation: erection sub-score(End of treatment)
- MSHQ ejaculation: satisfaction sub-score(End of treatment)
- Quality of Life(End of treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With AlfuzosinProstatic HyperplasiaNCT00486785Sanofi431
已完成
不适用
Benign Prostatic Hyperplasia in TaiwanProstatic DiseasesNCT00941343Sanofi362
终止
不适用
Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic HyperplasiaBenign Prostatic HyperplasiaNCT01789840Merit Medical Systems, Inc.59
Unknown
不适用
Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for Benign Prostatic HyperplasiaBenign Prostatic HyperplasiaNCT04236687Germans Trias i Pujol Hospital100
终止
2 期
Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 GramsProstatic HyperplasiaNCT02396420South Florida Medical Imaging, PA2