At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 606 enrolled
Drug / intervention
Tadalafil +1 moredrug
Likely dose
Placebo 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, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men With Both Erectile Dysfunction and Benign Prostatic Hyperplasia
In Brief
A Phase 3 clinical trial evaluating Tadalafil and Placebo for Erectile Dysfunction and Benign Prostatic Hyperplasia. Completed, enrolled 606 participants across 52 sites in 9 countries.
Detailed Summary
Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErectile Dysfunction, Benign Prostatic Hyperplasia
CountriesCanada, France, Germany, Greece, Italy, Mexico, Portugal, Russia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedMar 2009
Primary CompletionJul 2010
TodayJul 2026
First PostedMar 4, 2009
Enrollment StartMar 1, 2009
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.3 years ago
Interventions
Tadalafildrug
tablet once daily by mouth for 12 weeks.
Placebodrug
Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.