The Efficacy and Safety of the Combination of Tamsulosin and Tadalafil in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia and Erectile Dysfunction

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The efficacy and safety of the combination of tamsulosin and tadalafil in men with lower urinary tract symptoms due to benign prostatic hyperplasia and Erectile Dysfunction: a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IlDong Pharmaceutical Co Ltd
• Treatments: Tadalafil; Tamsulosin

Criteria

Inclusion Criteria:

Visit1

• Male aged 45 years old or older

• Subjects who have PSA ≤ 4.0 ng/mL Visit2

• Subjects who have Total IPSS score ≥ 13

• Subjects who have IIEF-EF domain ≤ 24 and each point below 3 in question 3 and 4

Exclusion Criteria:

• Subjects who have hypersensitivity to investigational product or sulfa medications