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

Study Overview
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Brief Summary
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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

Conditions
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Benign Prostatic Hyperplasia, Erectile Dysfunction

Intervention / Treatment
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* Drug: Tamsulosin 0.2mg
* Drug: Tadalafil 5mg
* Drug: Placebo for Tamsulosin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Visit1 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 Exclusion Criteria: Subjects who have hypersensitivity to investigational product or sulfa medications

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Tamsulosin 0.2mg and Tadalafil 5mg | Drug: Tamsulosin 0.2mg<br> <br> Drug: Tadalafil 5mg<br> <br> |
| Active Comparator: Comparator<br>placebo for Tamsulosin 0.2mg and Tadalafil 5mg | Drug: Tadalafil 5mg<br> <br> Drug: Placebo for Tamsulosin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of total IPSS(International prostate symptom score) |  | From baseline at week 12 | 
| The change of IIEF-EF(International Index of Erectile Function sum of questions-Erectile function) domain |  | From baseline at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The change of IPSS(International prostate symptom score) QoL(Quality of Life) |  | From baseline at week 4,8 and 12 | 
| The change of Qmax(maximum urinary flow rate) |  | From baseline at week 4,8 and 12 | 
| The change of PVR(Post Void Residual Volume) |  | From baseline at week 4,8 and 12 | 
| PGIC(Patient Global Impression of change) score |  | At week 12 | 
| CGIC(Clinician 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 OS(Overall satisfaction) domain score measured by IIEF question number13 and 14 |  | 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 IIEF(International Index of Erectile Function) score about questions number 3 and 4 |  | From baseline at week 12 | 
| The percentage of patients who have more than 4 point about IIEF questions number 3 and 4 |  | From baseline at week 12 | 
| 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 |