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

Erectile Dysfunction Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02862483
• Other study ID #: ID-TATA-301
• Status: Recruiting
• Phase: Phase 3
• First received: July 22, 2016
• Last updated: August 10, 2016
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2016
• Source: IlDong Pharmaceutical Co Ltd
• Contact: Ji-yoon Choi
• Email: jychoi[@]ildong.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Erectile Dysfunction
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• Tamsulosin 0.2mg

• Tadalafil 5mg

• Placebo for Tamsulosin

Locations

Country	Name	City	State
Korea, Republic of	Catholic university of korea, Seoul ST. Mary's Hospital.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of total IPSS(International prostate symptom score)		From baseline at week 12	No
Primary	The change of IIEF-EF(International Index of Erectile Function sum of questions-Erectile function) domain		From baseline at week 12	No
Secondary	The change of total IPSS(International prostate symptom score)		From baseline at week 4,8	No
Secondary	The change of total IPSS(International prostate symptom score) sub score (storage, voiding)		From baseline at week 4,8 and 12	No
Secondary	The change of IPSS(International prostate symptom score) QoL(Quality of Life)		From baseline at week 4,8 and 12	No
Secondary	The change of Qmax(maximum urinary flow rate)		From baseline at week 4,8 and 12	No
Secondary	The change of PVR(Post Void Residual Volume)		From baseline at week 4,8 and 12	No
Secondary	PGIC(Patient Global Impression of change) score		At week 12	No
Secondary	CGIC(Clinician Global Impression of change) score		At week 12	No
Secondary	The change of IIEF (International Index of Erectile Function sum of questions) total score		From baseline at week 4,8 and 12	No
Secondary	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	No
Secondary	The change of OS(Overall satisfaction) domain score measured by IIEF question number13 and 14		From baseline at week 4,8 and 12	No
Secondary	The change of OF(Orgasmic function) domain score measured by IIEF question number 9 and 10)		From baseline at week 4,8 and 12	No
Secondary	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	No
Secondary	The change of IIEF(International Index of Erectile Function) score about questions number 3 and 4		From baseline at week 12	No
Secondary	The percentage of patients who have more than 4 point about IIEF questions number 3 and 4		From baseline at week 12	No
Secondary	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	No