Clinical trial to evaluate the efficacy and safety of GUGUTAMS capsule
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0002940
- Lead Sponsor
- Kangdong Sacred Heart Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 404
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 m
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method