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

Phase 3

• Conditions: Erectile Dysfunction; Benign Prostatic Hyperplasia
• Interventions: Drug: Tamsulosin 0.2mg; Drug: Tadalafil 5mg; Drug: Placebo for Tamsulosin

• Registration Number: NCT02862483
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-07-22
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-07
• Last Update Submitted: 2016-08-10
• Study First Posted: 2016-08-11
• Last Update Posted: 2016-08-12
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Tamsulosin 0.2mg	Tamsulosin 0.2mg and Tadalafil 5mg
Experimental	Tadalafil 5mg	Tamsulosin 0.2mg and Tadalafil 5mg
Comparator	Placebo for Tamsulosin	placebo for Tamsulosin 0.2mg and Tadalafil 5mg
Comparator	Tadalafil 5mg	placebo for Tamsulosin 0.2mg and Tadalafil 5mg

Primary Outcome Measures

Name	Time	Method
The change of IIEF-EF(International Index of Erectile Function sum of questions-Erectile function) domain	From baseline at week 12
The change of total IPSS(International prostate symptom score)	From baseline at week 12

Secondary Outcome Measures

Name	Time	Method
The change of total IPSS(International prostate symptom score)	From baseline at week 4,8
CGIC(Clinician Global Impression of change) score	At week 12
The change of IIEF(International Index of Erectile Function) score about questions number 3 and 4	From baseline at week 12
The percentage of patients who have increased score about IIEF questions number 3 and 4(at least 1 point) compared to the baseline	From baseline at week 12
The change of IPSS(International prostate symptom score) QoL(Quality of Life)	From baseline at week 4,8 and 12
The change of PVR(Post Void Residual Volume)	From baseline at week 4,8 and 12
The change of total IPSS(International prostate symptom score) sub score (storage, voiding)	From baseline at week 4,8 and 12
PGIC(Patient Global Impression of change) score	At week 12
The change of IIEF (International Index of Erectile Function sum of questions) total score	From baseline at week 4,8 and 12
The change of IIEF-IS(International Index of Erectile Function sum of questions-Intercourse satisfaction) domain score measured by IIEF question number 6~8	From baseline at week 4,8 and 12
The change of OF(Orgasmic function) domain score measured by IIEF question number 9 and 10)	From baseline at week 4,8 and 12
The change of IIEF-EF domain(International Index of Erectile Function sum of questions-Erectile function) score measured by IIEF question number 1~5 and 15	From baseline at week 4,8
The change of Qmax(maximum urinary flow rate)	From baseline at week 4,8 and 12
The change of OS(Overall satisfaction) domain score measured by IIEF question number13 and 14	From baseline at week 4,8 and 12
The percentage of patients who have more than 4 point about IIEF questions number 3 and 4	From baseline at week 12

Trial Locations

Locations (1)

Catholic university of korea, Seoul ST. Mary's Hospital.; 🇰🇷 Seoul, Korea, Republic of