Efficacy and Safety of the Coadministration of Tadarafil with Dutasteride in Men with Benign Prostatic Hyperplasia: A Phase III Randomized Open-Label Study
Phase 3
- Conditions
- Benign Prostatic Hyperplasia
- Registration Number
- JPRN-UMIN000016796
- Lead Sponsor
- Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 560
Inclusion Criteria
Not provided
Exclusion Criteria
1) Prostate cancer 2) Nerogenic bladder 3) no administration of Dutasteride, Finasteride, anti-androgen, and testosterone within 6 months 4) no administration of drugs for overactive bladder and BPH exclude a1-blocker 5) no administration of PDE5 inhibitors 6) contraindication of Dutasteride 7) contraindication of Tadarafil
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total international prostate symptom score on 12 weeks after administration
- Secondary Outcome Measures
Name Time Method Total IPSS on 24 weeks after administration IPSS sub-score, OABSS, IIEF, EHS, AMS Score, Uroflowmetry, Post-voided residual volume, adverse effect, BMI, blood pressure, waist size, prostate volume, Plaque score on 4, 12, and 24 weeks