A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules

A Multicenter, Randomized, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules

The main objective of this study is to evaluate efficacy and safety of HCP1301 capsule in patients with Benign Prostatic Hyperplasia and Erectile Dysfunction

A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of HCP1303 capsule

Inclusion Criteria:

• At Visit 1

  1. ≥50 age
  2. BPH(Benign Prostatic Hyperplasia) + Total IPSS(International Prostate Symptom Score) ≥ 13
  3. Abnormal Erectile function ≥ at least 3months based on screening date

• At Visit 2 1. Total IPSS ≥ 13

Exclusion Criteria:

1. History of hypersensitivity to Tamsulosin or Tadalafil
2. History of allergy for Sulfonamide
3. PSA (Prostate Specific Antigen) ≥4ng/mL