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

IlDong Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Erectile Dysfunction; Benign Prostatic Hyperplasia

Treatments: Drug: Tadalafil 5mg; Drug: Tamsulosin 0.2mg; Drug: Placebo for Tamsulosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02862483

ID-TATA-301

Details and patient eligibility

About

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

Enrollment: 330 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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330 participants in 2 patient groups

Experimental

Experimental group

Description:

Tamsulosin 0.2mg and Tadalafil 5mg

Treatment:

Drug: Tadalafil 5mg

Drug: Tamsulosin 0.2mg

Comparator

Active Comparator group

Description:

placebo for Tamsulosin 0.2mg and Tadalafil 5mg

Treatment:

Drug: Tadalafil 5mg

Drug: Placebo for Tamsulosin