Benign Prostatic Hyperplasia, Erectile Dysfunction
Conditions
Brief summary
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
Interventions
Sponsors
IlDong Pharmaceutical Co Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 total IPSS(International prostate symptom score) | From baseline at week 4,8 |
| 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 |
| 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 total IPSS(International prostate symptom score) sub score (storage, voiding) | From baseline at week 4,8 and 12 |
Countries
South Korea
Contacts
Primary ContactJi-yoon Choi
Outcome results
None listed