search
Back to results

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

Primary Purpose

Benign Prostatic Hyperplasia, Erectile Dysfunction

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tamsulosin 0.2mg
Tadalafil 5mg
Placebo for Tamsulosin
Sponsored by
IlDong Pharmaceutical Co Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Comparator

Arm Description

Tamsulosin 0.2mg and Tadalafil 5mg

placebo for Tamsulosin 0.2mg and Tadalafil 5mg

Outcomes

Primary Outcome Measures

The change of total IPSS(International prostate symptom score)
The change of IIEF-EF(International Index of Erectile Function sum of questions-Erectile function) domain

Secondary Outcome Measures

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

Full Information

First Posted
July 22, 2016
Last Updated
August 10, 2016
Sponsor
IlDong Pharmaceutical Co Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT02862483
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IlDong Pharmaceutical Co Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Tamsulosin 0.2mg and Tadalafil 5mg
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
placebo for Tamsulosin 0.2mg and Tadalafil 5mg
Intervention Type
Drug
Intervention Name(s)
Tamsulosin 0.2mg
Intervention Type
Drug
Intervention Name(s)
Tadalafil 5mg
Intervention Type
Drug
Intervention Name(s)
Placebo for Tamsulosin
Primary Outcome Measure Information:
Title
The change of total IPSS(International prostate symptom score)
Time Frame
From baseline at week 12
Title
The change of IIEF-EF(International Index of Erectile Function sum of questions-Erectile function) domain
Time Frame
From baseline at week 12
Secondary Outcome Measure Information:
Title
The change of total IPSS(International prostate symptom score)
Time Frame
From baseline at week 4,8
Title
The change of total IPSS(International prostate symptom score) sub score (storage, voiding)
Time Frame
From baseline at week 4,8 and 12
Title
The change of IPSS(International prostate symptom score) QoL(Quality of Life)
Time Frame
From baseline at week 4,8 and 12
Title
The change of Qmax(maximum urinary flow rate)
Time Frame
From baseline at week 4,8 and 12
Title
The change of PVR(Post Void Residual Volume)
Time Frame
From baseline at week 4,8 and 12
Title
PGIC(Patient Global Impression of change) score
Time Frame
At week 12
Title
CGIC(Clinician Global Impression of change) score
Time Frame
At week 12
Title
The change of IIEF (International Index of Erectile Function sum of questions) total score
Time Frame
From baseline at week 4,8 and 12
Title
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
Title
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
Title
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
Title
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
Title
The change of IIEF(International Index of Erectile Function) score about questions number 3 and 4
Time Frame
From baseline at week 12
Title
The percentage of patients who have more than 4 point about IIEF questions number 3 and 4
Time Frame
From baseline at week 12
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-yoon Choi
Email
jychoi@ildong.com
Facility Information:
Facility Name
Catholic university of korea, Seoul ST. Mary's Hospital.
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sae Woong Kim

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs