None listed
Conditions
Interventions
Drug : This study is designed as multi-center, randomized, active-controlled, double-blinded study, with the aim to evaluate efficacy and safety of GUGUTAMS Capsule 5/0.4mg (Tadalafil 5mg + Tamsulosin
Sponsors
Kangdong Sacred Heart Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: At Visit 1 1. Males, 50 years or older 2. diagnosed with BPH 3. Subjects who provide signed informed consent at the start of the study At Visit 2 1. Subjects with the Total International Prostate Symptom Score (IPSS) greater than or equal to 13 2. Subjects who have peak flow rate (Qmax) = 4 mL/sec and = 15 mL/sec, minimum voided volume = 150mL 3. Subjects who have postvoid residual volume (PVR) < 150 mL
Exclusion criteria
Exclusion criteria: 1. Subjects who show hypersensitivity to the investigational products and the components. 2. Subjects who have sulfonamide allergy 3. Subjects whose Prostate-Specific Antigen (PSA) values are greater than 4ng/mL (subjects with a PSA = 4ng/mL are required to have a prostate biopsy negative for malignance) 4.Subjects with the clinical evidence of urinary tract infection/ inflammation or other urology diseases except BPH 5. Subjects with clinical evidence of genito-urinary malignant tumors including prostate or bladder cancer. 6. Subjects who have history of prostate surgery or who are scheduled prostate surgery. 7. Subjects who had cystoscopy or catheter procedure 8. Subjects who had AUR within 3 months 9. Subjects with orthostatic hypotension 10. Subjects who have history of orthostatic hypotension with taking a-blocker for the first time. 11. Subjects with uncontrollable diabetes (HbA1c exceeding 9%) 12. Subjects who have taken other BPH therapy (including herbal preparations), overactive bladder (OAB) therapy, or erectile dysfunction (ED) at Visit 1 13. Subjects who have taken Finasteride, Dutasteride and hormone therapy for before Visit 1 14. Subjects with severe hepatic impairment (Child-Pugh Class C) 15. Subjects with clinical evidence of severe renal impairment (Scr > 2 mg/dl) 16. Subjects who experienced myocardial infarction within the last 90 days 17. Subjects who experienced New York Heart Association Class 2 or greater heart failure in the last 6 months 18. Subjects who have unstable angina or had angina during intercourse 19. Subjects with hypotension (sitSBP<90 mmHg or sitDBP<50mmHg), or uncontrolled hypertension (sitSBP >170 mmHg or sitDBP >100 mmHg) 20. Subjects with hereditary retinal degenerative diseases including retinitis pigmentosa 21. Subjects with vision loss of one eye due to Non-arteritic anterior ischemic optic neuropathy, (NAION) 22. Subjects with certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord 23. Subjects with galactose intolerance,Lapp lactase deficiency, glucose-galactose malabsorption 24. Subjects with history or current evidence of alcohol or drug abuse 25. Subjects who have no intention of using a proper contraceptive method 26. Subjects who have participated in other clinical studies to have been dosed other investigational products or other treatment. 27. Subjects who are judged to be inappropriate to enroll in study from discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of Total International Prostate Symptom Score | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of Total International Prostate Symptom Score | — |
Countries
Korea, Republic of
Contacts
Public ContactDaeYul Yang
Kangdong Sacred Heart Hospital
Outcome results
None listed