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
Abstract
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.
Conditions: Erectile Dysfunction, Benign Prostatic Hyperplasia.
Primary outcome: Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg); Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg); Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg); Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg).
Enrollment: 606 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 606 participants or records.
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