NCT00486785已完成4 期
Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL OD 10mg), 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
- 431
- 试验地点
- 1
- 主要终点
- Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function.
研究概览
简要总结
Primary Objective:
- To assess the sexual function improvement from baseline to the end of treatment (Week 24 or premature withdrawal (PW)) with XATRAL 10mg OD.
Secondary Objective:
- To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and sexual disorders,
- To compare the improvement in sexual function, urinary symptoms and Quality of Life among the different regions,
- To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-Item version of the International Index of Erectile Function),
- To assess the onset of action of XATRAL 10mg OD,
- To assess the peak flow rate improvement (Qmax),
- To assess the safety and the tolerability of XATRAL 10mg OD.
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH),
- •Patients with an I-PSS total score ≥ 8,
- •Patients sexually active
排除标准
- •Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant threatening-life condition.
- •Previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. Planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period.
- •Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer.
- •Patients having received 5α-reductase inhibitors or LUTS related phytotherapy within 6 months prior to inclusion, or α1-blockers within 30 days prior to inclusion. Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion.
- •History of postural hypotension or syncope.
- •Known hypersensitivity to alfuzosin.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: Alfuzosin (Drug)
结局指标
主要结局
Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function.
时间窗: 24 weeks
Evaluation of adverse events, vital signs (blood pressure and heart rate), PSA (Prostate-specific antigen; mandatory at baseline and optional at the end of treatment) and serum creatinine assessment (optional at baseline and at the end of treatment)
时间窗: 24 weeks
次要结局
- - Mean change from baseline to 4, 12, and 24 weeks of treatment in MSHQ in the ejaculation score - Mean change from baseline to 4, 12 and 24 weeks of treatment in MSHQ ejaculation questions, in the erection questions and sexual activity and desire(24 weeks)
- - Mean change from baseline to week 1 in I-PSS total score and sub-scores (objective onset of action) - Onset of action based on patient perception (questionnaire at Week 1)(24 weeks)
- -Mean change from baseline to 4,12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life -QOL Mean change from baseline to 4, 12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life(24 weeks)
研究者
研究点 (1)
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