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

August 10, 2016 updated by: IlDong Pharmaceutical Co Ltd
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Catholic University of Korea, Seoul ST. Mary's Hospital.
        • Principal Investigator:
          • Sae Woong Kim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Tamsulosin 0.2mg and Tadalafil 5mg
Drug: Tamsulosin 0.2mg
Drug: Tadalafil 5mg
Active Comparator: Comparator
placebo for Tamsulosin 0.2mg and Tadalafil 5mg
Drug: Tadalafil 5mg
Drug: Placebo for Tamsulosin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The change of total IPSS(International prostate symptom score)
Time Frame: From baseline at week 4,8
From baseline at week 4,8
The change of total IPSS(International prostate symptom score) sub score (storage, voiding)
Time Frame: From baseline at week 4,8 and 12
From baseline at week 4,8 and 12
The change of IPSS(International prostate symptom score) QoL(Quality of Life)
Time Frame: From baseline at week 4,8 and 12
From baseline at week 4,8 and 12
The change of Qmax(maximum urinary flow rate)
Time Frame: From baseline at week 4,8 and 12
From baseline at week 4,8 and 12
The change of PVR(Post Void Residual Volume)
Time Frame: From baseline at week 4,8 and 12
From baseline at week 4,8 and 12
PGIC(Patient Global Impression of change) score
Time Frame: At week 12
At week 12
CGIC(Clinician Global Impression of change) score
Time Frame: At week 12
At week 12
The change of IIEF (International Index of Erectile Function sum of questions) total score
Time Frame: From baseline at week 4,8 and 12
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
Time Frame: From baseline at week 4,8 and 12
From baseline at week 4,8 and 12
The change of OS(Overall satisfaction) domain score measured by IIEF question number13 and 14
Time Frame: From baseline at week 4,8 and 12
From baseline at week 4,8 and 12
The change of OF(Orgasmic function) domain score measured by IIEF question number 9 and 10)
Time Frame: From baseline at week 4,8 and 12
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
Time Frame: From baseline at week 4,8
From baseline at week 4,8
The change of IIEF(International Index of Erectile Function) score about questions number 3 and 4
Time Frame: From baseline at week 12
From baseline at week 12
The percentage of patients who have more than 4 point about IIEF questions number 3 and 4
Time Frame: From baseline at week 12
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
Time Frame: From baseline at week 12
From baseline at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IlDong Pharmaceutical Co Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

August 7, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID-TATA-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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