NCT02862483Unknown3 期
The Efficacy and Safety of the Combination of Tamsulosin and Tadalafil in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia and Erectile Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- The change of IIEF-EF(International Index of Erectile Function sum of questions-Erectile function) domain
研究概览
简要总结
The efficacy and safety of the combination of tamsulosin and tadalafil in men with lower urinary tract symptoms due to benign prostatic hyperplasia and Erectile Dysfunction: a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged 45 years old or older
- •Subjects who have PSA ≤ 4.0 ng/mL Visit2
- •Subjects who have Total IPSS score ≥ 13
- •Subjects who have IIEF-EF domain ≤ 24 and each point below 3 in question 3 and 4
排除标准
- •Subjects who have hypersensitivity to investigational product or sulfa medications
研究组 & 干预措施
Experimental
Experimental
Tamsulosin 0.2mg and Tadalafil 5mg
干预措施: Tamsulosin 0.2mg (Drug)
Experimental
Experimental
Tamsulosin 0.2mg and Tadalafil 5mg
干预措施: Tadalafil 5mg (Drug)
Comparator
Active Comparator
placebo for Tamsulosin 0.2mg and Tadalafil 5mg
干预措施: Tadalafil 5mg (Drug)
Comparator
Active Comparator
placebo for Tamsulosin 0.2mg and Tadalafil 5mg
干预措施: Placebo for Tamsulosin (Drug)
结局指标
主要结局
The change of IIEF-EF(International Index of Erectile Function sum of questions-Erectile function) domain
时间窗: From baseline at week 12
The change of total IPSS(International prostate symptom score)
时间窗: From baseline at week 12
次要结局
- The percentage of patients who have increased score about IIEF questions number 3 and 4(at least 1 point) compared to the baseline(From baseline at week 12)
- CGIC(Clinician Global Impression of change) score(At week 12)
- The change of IIEF(International Index of Erectile Function) score about questions number 3 and 4(From baseline at week 12)
- The change of IPSS(International prostate symptom score) QoL(Quality of Life)(From baseline at week 4,8 and 12)
- The change of PVR(Post Void Residual Volume)(From baseline at week 4,8 and 12)
- The change of total IPSS(International prostate symptom score)(From baseline at week 4,8)
- The change of total IPSS(International prostate symptom score) sub score (storage, voiding)(From baseline at week 4,8 and 12)
- PGIC(Patient Global Impression of change) score(At week 12)
- The change of IIEF (International Index of Erectile Function sum of questions) total score(From baseline at week 4,8 and 12)
- The change of IIEF-IS(International Index of Erectile Function sum of questions-Intercourse satisfaction) domain score measured by IIEF question number 6~8(From baseline at week 4,8 and 12)
- The change of OF(Orgasmic function) domain score measured by IIEF question number 9 and 10)(From baseline at week 4,8 and 12)
- The change of IIEF-EF domain(International Index of Erectile Function sum of questions-Erectile function) score measured by IIEF question number 1~5 and 15(From baseline at week 4,8)
- The change of Qmax(maximum urinary flow rate)(From baseline at week 4,8 and 12)
- The change of OS(Overall satisfaction) domain score measured by IIEF question number13 and 14(From baseline at week 4,8 and 12)
- The percentage of patients who have more than 4 point about IIEF questions number 3 and 4(From baseline at week 12)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Effect of Tamsulosin vs Tadalafil on ureteric and renal stone clearance in patients receiving shock treatmentCTRI/2018/01/011217Christian Medical College and Hospital Vellore250
已完成
不适用
Efficacy of Tamsulosin plus Tadalafil versus Tamsulosin as medical expulsive therapy for lower ureteric stones: A randomized controlled trialStudy CompletedJPRN-UMIN000038125Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital176
已完成
4 期
Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia Long Term StudyBPHNCT05818670Mansoura University160
尚未招募
3 期
To compare the efficacy and impact on sexual function of combination of Tadalafil and Tamsulosin versus Tamsulosin alone in the management of Benign prostatic hyperplasia in patients attending Lagos State University Teaching HospitalUrological and Genital DiseasesPACTR202311592558473Atobatele Kazeem182
已完成
不适用
Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe LUTS Due to BPHProstate DiseaseProstate ObstructionProstate HypertrophyProstatic NeoplasmsNCT05834270Menoufia University60