Efficacy and Safety of the Tadarafil Monotherapy or 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-UMIN000019323
- Lead Sponsor
- Department of Urology Uonuma Institute of Community Medicine Niigata University Medical and Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1) Prostate cancer 2) Neurogenic bladder 3) no administration of drugs for overactive bladder and BPH exclude a1-blocker 4) no administration of Dutasteride, Finasteride, anti-androgen, and testosterone within 6 months 5) no administration of PDE5 inhibitors 6) contraindication of Tadarafil 7) contraindication of Dutasteride
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, IIEF5, AMS Score, SF-8, Uroflowmetry, Post-voided residual volume, prostate volume, blood pressure, adverse effect on 4, 12, and 24 weeks