028 Efficacy and Safety of Fixed Dose Combination of Tamsulosin and Tadalafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
Abstract
The aim of this study was to evaluate the efficacy and safety of once-daily fixed dose combination (FDC) of tamsulosin and tadalafil in patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) in comparison to tadalafil mono-therapy. In a phase III, multi-center, randomized, double-blinded and placebo-controlled clinical trial, participants were randomly assigned to active treatment groups of either FDCs consisting tamsulosin 0.4 or 0.2mg in combination of tadalafil 5mg or mono-component of tadalafil 5mg for 12-week treatment period, followed by an open-label extension period that continued up to week 24, while being treated with FDC of tamsulosin 0.4 mg and tadalafil 5mg. The primary efficacy variables of the study were assessed after 12 weeks of treatment using the international prostate symptom score (IPSS) and International Index of Erectile Function (IIEF). Other assessments included Sexual Encounter Profile, Global Assessment Question, Qmax, PSA, and PVR. Eligible patients were men aged over 45 years with BPH confirmed by total IPSS greater than or equal to 13 and ED persistent for longer than 3 months.
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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.
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