At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 151 enrolled
Drug / intervention
Tadalafil +2 moredrug
Likely dose
Tadalafil 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Pilot Study to Evaluate the Efficacy and Safety of Tadalafil and Tamsulosin Once-a-Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
In Brief
A Phase 2 clinical trial evaluating Tadalafil, Placebo, and 1 other intervention for Benign Prostatic Hyperplasia. Completed, enrolled 151 participants across 5 sites.
Detailed Summary
The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia
CountriesSouth Korea
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedOct 2007
Primary CompletionJun 2008
TodayJul 2026
First PostedOct 5, 2007
Enrollment StartOct 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.7 years ago
Interventions
Tadalafildrug
5 mg once a day
Placebodrug
once a day
Tamsulosindrug
0.2 mg once a day