A Randomized, Open-Label, Multicenter study evaluating efficacy of switch from dutasteride to tadalafil in benign prostatic hyperplasia patient with lower urinary tract symptoms
- Conditions
- benign prostatic hyperplasia
- Registration Number
- JPRN-UMIN000020369
- Lead Sponsor
- Hirosaki University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 200
Not provided
Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1. History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1. History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1. Clinical evidence of prostate cancer at Visit 1. Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1. History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study. History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1. Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to tadalafil.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS)
- Secondary Outcome Measures
Name Time Method Change from Baseline to 12 Week Endpoint in IPSS Irritative Subscore, IPSS Voiding (Obstructive) Subscore, IPSS Quality of Life (QoL) Index, Uroflowmetry Parameter: Peak Flow Rate (Qmax), Number of Participants With Adverse Events International Index of Erectile Function (IIEF), Blood Pressure,ostvoid Residual Volume (PVR), Prostate Specific Antigen (PSA),testosterone, oxygen stress