Conditions: Benign Prostatic Hyperplasia
Keywords: Prostatic hyperplasia Benign prostatic hyperplasia Lower urinary tract
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 610
Healthy volunteers: no

Brief summary:
This is a phase 3, randomized, double-blind, placebo-controlled, parallel-design, multinational study to evaluate the efficacy and safety of tadalafil once-a-day dosing for 12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia.

Detailed description:
Tadalafil is being investigated as a treatment for men with signs and symptoms of benign prostatic hyperplasia \[BPH; also referred to as urinary disturbance or BPH-LUTS (BPH-lower urinary tract symptoms)\] in Japan and overseas. Overseas studies and the Japanese dose-finding study LVIA (NCT00783094) identified tadalafil 5 mg once-daily as the recommended dose. The long-term safety and maintenance of effect was confirmed in the open-label extension of study LVIA. The risk-benefit profile was further studied in the Asian study LVHB (NCT00861757).

This study, LVJF, is to confirm the efficacy and safety of tadalafil 5 mg once-daily in Asian men with BPH-LUTS.

Arms:
arm 1: Following the 4-week placebo lead-in period, this arm will consist of a 12-week placebo treatment period involving 2 x 2.5-milligram (mg) tadalafil placebo tablets taken orally once daily. arm 2: Following the 4-week placebo lead-in period, this arm will consist of a 12-week treatment period involving 2 x 2.5-mg tadalafil tablets taken orally once daily.

Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg (2 x 2.5-mg tablets), given once daily as oral tablet intervention 2: 2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily.

Protocol document: