French Study in Real Life Evaluating Xybilun: Convenience and Erection Induction Related to a New Administration in Orodispersible Film
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Patients who has never been treated for ED (group 1,2,3) : responder patients rate at V3 (IIEF-6 : international index of erectil function)
研究概览
简要总结
Collecting Xybilun (Viagra's generic) efficacity, tolerance, convenience and patients/doctors satisfaction's data at different doses (50-75-100 mg), is the aim of the study.
详细描述
Study design
Population Patients without prior treatment with a first Xybilun prescription Patients already treated for who the treatment is remplaced by Xybilun
Study perimeter 400 patients 50 investigators (sexologists, urologists)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age > or equal 18 years
- •Erectile dysfunction at V1 light (group 1), moderate (group 2), severe (group 3): IIEF-6 score between 6 and 25 (IIEF-6 questions 1-5 and question 15)
- •More than 3 sexual intercourse
- •First prescription of Xybilun (gr 1,2,3) or subtitution (gr 4)
- •Information and non-opposition
排除标准
- •Sildénafil hypersensitivity
- •Treatment with nitrogen oxide or guanylate cyclase
- •Patient with sexual intercourse prohibited
- •Alpha-blocker during past 3 months
- •Participation in an other clinical trial
- •Patient unable to read properly an information sheet
- •Patient under guardianship/curatorship
研究组 & 干预措施
Xybilun: mild erectil dysfunction
Patient who has never been treated for his ED (erectil dysfunction), with mild ED (score IIEF-6 between 22 and 25) and begin treatment at 50 mg
干预措施: Xybilun (Drug)
Xybilun: moderate erectil dysfunction
Patient who has never been treated for his ED (erectil dysfunction), with moderate ED (score IIEF-6 between 11 and 21) and begin treatment at 50 mg
干预措施: Xybilun (Drug)
Xybilun: severe erectil dysfunction
Patient who has never been treated for his ED (erectil dysfunction), with severe ED (score between 6 and 10) and begin treatment at 50 mg
干预措施: Xybilun (Drug)
Xybilun switch
Substitution dose to dose of previous treatment by Xybilun whatever the severity of ED.
干预措施: Xybilun (Drug)
结局指标
主要结局
Patients who has never been treated for ED (group 1,2,3) : responder patients rate at V3 (IIEF-6 : international index of erectil function)
时间窗: 3 months
Group 1: patient good responder if there is an increase of at least 2 points regarding score of IIEF-6; Group 2: patient good responder if there is an increase of at least 5 points regarding score of IIEF-6; Group 3: patient good responder if there is an increase of at least 7 points regarding score of IIEF-6;
Patients with treatment substitution (group 4): satisfaction of Xybilun vs previous treatment at V3 (Likert scale 5 points : 1-Not satisfied at all, 2-not very satisfied, 3-nor satisfied nor unsatisfied, 4- satisfied, 5-very satisfied)
时间窗: 3 months
Likert scale in 5 point evaluated at V3: "Are you more satisfied regarding you previous treatment then your current treatment?" Patient improved if his answer is "satisfied" (score 4) or "very satisfied" (score 5).
次要结局
- Patients who has never been treated for ED (group 1,2,3) : responder patients at V2 Month 1 (IIEF-6)(1 month)
- Patients who has never been treated for ED (group 1,2,3) : overall satisfaction at 1 month and 3 month(1 month and 3 months)
- Patients who has never been treated for ED (group 1,2,3) : Patient Xybilun and investigator satisfaction at V2 month 1 and V3 month 3(1 month and 3 months)
- Patients who has never been treated for ED (group 1,2,3) : convenience at V2 month 1 and V3 month 3 (Likert scale)(1 month and 3 months)
- Patients who has never been treated for ED (group 1,2,3) : Partner satisfaction (Likert scale) at month 3(3 months)
- Patients with treatment substitution (group 4): International index of erectile function (IIEF) evolution (IIEF15)(1 month and 3 months)
- Patients with treatment substitution (group 4): satisfaction (patient/investigator) of previous treatment evaluated at V1 (Day 0) (Likert scale)(Day 0)
- Patients with treatment substitution (group 4): satisfaction of Xybilun (patient/investigator) at V2 month 1 and V3 month 3 (Likert scale)(1 month and 3 months)
- Patients with treatment substitution (group 4): convenience previous treatment at V1 (day 0) (Likert scale)(Day 0)
- Patients with treatment substitution (group 4): reasons of treatment substitution(Day 0)
- Patients with treatment substitution (group 4): efficacy of Xybilun comparing score IIEF-6 before/after treatment(1 month and 3 months)
- safety(1 month and 3 months)
- Patients with treatment substitution (group 4): convenience Xybilun (patient) at V2 month 1 and V3 month 3 (Likert scale)(1 month and 3 months)
- Patients with treatment substitution (group 4): Partner satisfaction at V3 month 3 (Likert scale)(3 months)