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

Last updated: August 10, 2016
Sponsor: IlDong Pharmaceutical Co Ltd
Overall Status: Trial Status Unknown

Phase

3

Condition

Erectile Dysfunction

Prostate Disorders

Enuresis

Treatment

N/A

Clinical Study ID

NCT02862483
ID-TATA-301
  • Ages > 45
  • Male

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Subjects who have hypersensitivity to investigational product or sulfa medications

Study Design

Total Participants: 330
Study Start date:
March 01, 2016
Estimated Completion Date:
March 31, 2017

Connect with a study center

  • Catholic university of korea, Seoul ST. Mary's Hospital.

    Seoul,
    Korea, Republic of

    Active - Recruiting

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