At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
In Brief
A Phase 3 clinical trial evaluating tadalafil and placebo for Benign Prostatic Hyperplasia. Completed, enrolled 1,058 participants across 1 site.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms.
Study Details
Timeline
Interventions
2.5 mg tadalafil tablet by mouth once a day for twelve weeks.
5 mg tadalafil tablet by mouth once a day for twelve weeks.
10 mg tadalafil tablet by mouth once a day for twelve weeks.
20 mg tadalafil tablet by mouth once a day for twelve weeks.
Placebo tablet taken by mouth one a day for twelve weeks