A Phase 3, Double Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Alfuzosin in Treating Men With ED and Mild LUTS.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change From Baseline Erectile Function Domain of the International Index of Erectile Function
研究概览
简要总结
The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function (EF) domain of International Index of Erectile Function (IIEF).
详细描述
This protocol is a placebo-controlled, double-blind, crossover trial. Patients will be screened and then randomized to Group A or Group B at a 1:1 ratio to receive a placebo tablet once daily or Alfuzosin (10 mg) daily for 12 weeks. Patients will then crossover with the original placebo group receiving Alfuzosin for 12 weeks and the original Alfuzosin group receiving placebo. At every visit the patients will complete an IIEF and an AUA symptom index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, 30-69 years of age
- •Has mild to moderate Erectile Dysfunction with a score < 25 on EF domain in IIEF
- •AUA score of less than or equal to 14
- •Negative urinalysis with no evidence of a Urinary Tract Infection
排除标准
- •Blood pressure < 90/50 or > 170/110
- •Neurological disorder (MS, SCI, CVA, Parkinson's disease, ALS)
- •Diabetes Mellitus
- •History of PSA > 10
- •History of confirmed or suspected prostate cancer
- •History of Moderate/Severe Hepatic Insufficiency defined as > 2X ULN
- •On Alpha Blocker or PDE 5 inhibitor within 2 weeks of randomization
- •Receive treatment with other investigational agents within 30 days prior to enrollment
研究组 & 干预措施
Placebo, Then Alfuzosin
Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks.
干预措施: Placebo (Drug)
Placebo, Then Alfuzosin
Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks.
干预措施: Alfuzosin (Drug)
Alfuzosin, Then Placebo
Participants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks.
干预措施: Placebo (Drug)
Alfuzosin, Then Placebo
Participants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks.
干预措施: Alfuzosin (Drug)
结局指标
主要结局
Change From Baseline Erectile Function Domain of the International Index of Erectile Function
时间窗: Baseline and 12 Weeks
The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction.
次要结局
- Changes in American Urological Association (AUA) Symptom Index(Baseline and 12 Weeks)
- Change in Total International Index of Erectile Function (IIEF) Score(Baseline and 12 Weeks)