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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
330
Catholic university of korea, Seoul ST. Mary's Hospital.
Seoul, South Korea
RECRUITINGThe change of total IPSS(International prostate symptom score)
Time frame: From baseline at week 12
The change of IIEF-EF(International Index of Erectile Function sum of questions-Erectile function) domain
Time frame: From baseline at week 12
The change of total IPSS(International prostate symptom score)
Time frame: From baseline at week 4,8
The change of total IPSS(International prostate symptom score) sub score (storage, voiding)
Time frame: From baseline at week 4,8 and 12
The change of IPSS(International prostate symptom score) QoL(Quality of Life)
Time frame: From baseline at week 4,8 and 12
The change of Qmax(maximum urinary flow rate)
Time frame: From baseline at week 4,8 and 12
The change of PVR(Post Void Residual Volume)
Time frame: From baseline at week 4,8 and 12
PGIC(Patient Global Impression of change) score
Time frame: At week 12
CGIC(Clinician Global Impression of change) score
Time frame: At week 12
The change of IIEF (International Index of Erectile Function sum of questions) total score
Time frame: From baseline at week 4,8 and 12
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The change of IIEF-IS(International Index of Erectile Function sum of questions-Intercourse satisfaction) domain score measured by IIEF question number 6~8
Time frame: From baseline at week 4,8 and 12
The change of OS(Overall satisfaction) domain score measured by IIEF question number13 and 14
Time frame: From baseline at week 4,8 and 12
The change of OF(Orgasmic function) domain score measured by IIEF question number 9 and 10)
Time frame: 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
Time frame: From baseline at week 4,8
The change of IIEF(International Index of Erectile Function) score about questions number 3 and 4
Time frame: From baseline at week 12
The percentage of patients who have more than 4 point about IIEF questions number 3 and 4
Time frame: 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
Time frame: From baseline at week 12