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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Tamsulosin 0.2mg and Tadalafil 5mg |
|
| Comparator | Active Comparator | placebo for Tamsulosin 0.2mg and Tadalafil 5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin 0.2mg | Drug |
| ||
| Tadalafil 5mg |
| 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 |
| 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 |
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Inclusion Criteria:
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji-yoon Choi | Contact | jychoi@ildong.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic university of korea, Seoul ST. Mary's Hospital. | Recruiting | Seoul | South Korea |
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|
| Placebo for Tamsulosin | Drug |
|
| 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 |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
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