benign prostatic hyperplasia
Conditions
Interventions
Tadalafil 5mg one a day, for 12 weeks
No treatment, observation for 12 weeks
Sponsors
Hirosaki University Graduate School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Males, 20 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms who were taking dutasteride Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study Have not taken phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 1. Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShingo Hatakeyama
Hirosaki University Graduate School of Medicine Department of Urology
Outcome results
None listed