NCT00427882已完成4 期
An Open, Non-Comparative, Multicenter Study on the Sexual Function Improvement Following Treatment With Alfuzosin in Patients With Benign Prostate Hyperplasia
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Mean change from baseline to the end of treatment in the MSHQ ejaculation total score
研究概览
简要总结
Primary:
To assess improvement in ejaculation from baseline to the end of treatment (Week 12 or premature withdrawal) with Alfuzosin 10mg OD, using MSHQ score.
Secondary:
- To evaluate sexual function improvement
- To evaluate LUTS (Lower Uninary Tract Symptoms) improvement
- To evaluate the association between LUTS severity and sexual function.
- To assess the safety and the tolerability of Alfuzosin 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
- 40 Years 至 —（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) diagnosed by the Investigator
- •Patients with an I-PSS total score ≥ 8
- •Patients sexually active as defined by at least one of the following activities in the last 4 weeks: intercourse, caressing, foreplay, masturbation
排除标准
- •Patients with a known history of hepatic or severe renal insufficiency, unstable angina pectoris
- •Patients who had a previous prostate surgery
- •Patients who had a prostate biopsy or minimally invasive procedure within 6 months prior to inclusion
- •Patients with a prostate surgery or minimally invasive procedure during the whole study period
- •Patients with an active urinary tract infection or prostatitis
- •Patients with a neuropathic bladder defined as a spinal injury consequence or related to a neurological disorder or a known residual volume ≥ 350 ml
- •Patients with a diagnosed prostate cancer
- •Patients having received 5a-reductase inhibitors or LUTS related-phytotherapy within 6 months prior to inclusion, or a1-blockers within 30 days prior to inclusion
- •Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
- •Patients with a history of postural hypotension or syncope
- •Patients with a 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.
结局指标
主要结局
Mean change from baseline to the end of treatment in the MSHQ ejaculation total score
次要结局
- Mean change from baseline to 4 weeks in MSHQ ejaculation total score
- Mean change from baseline to 4 weeks and the end of treatment in MSHQ erection total score and in the satisfaction total score
- Mean change from baseline to 4 weeks and the end of treatment in MSHQ ejaculation questions, in the erection and satisfaction sub-scores
- Mean change from baseline to 4 weeks and the end of treatment in the I-PSS (International Prostate Symptom Score) total score and in the Quality of Life
- Mean change from baseline to 4 weeks and the end of treatment in I-PSS sub-scores for voiding, filling and nocturia symptoms
- Mean change from baseline to 4 weeks and the end of treatment in the peak urinary flow rate (Qmax)
- Correlation between MSHQ and IPSS
- Evaluation of adverse events, vital signs (blood pressure and heart rate in sitting position), PSA (Prostate Specific Antigen) and creatinine.
研究者
研究点 (2)
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