Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo
SK3530
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction, Diabetes Mellitus, SK3530
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of type 1 or type 2 diabetes.
- Score below 25 from IIEF EF domain during 4 weeks of treatment run-in period.
- Failure rate above 50% from sexual attempt above 4 during 4 weeks of treatment run-in period.
Exclusion Criteria:
- Lab abnormality.
- Uncontrolled diabetic mellitus(HbA1c > 12%).
- High or low blood pressure, orthostatic hypotension.
- Hyper- or hypo-thyroidism.
Sites / Locations
- SK Chemicals Co., Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire
Secondary Outcome Measures
the score from : 1) IIEF Q3 & Q4, 2) other domains of IIEF, 3) Sexual Encounter Profile(SEP)Q2 and Q3, 4) Life Satisfaction Checklist, 5) Global Efficacy Assessment Question(GEAQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00705861
Brief Title
Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus
Official Title
A 12 Week, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel Group, Fixed Dose Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of SK3530 on erectile dysfunction in Patients with Diabetes Mellitus.
Detailed Description
SK3530 is a potent and selective phosphdiesterase type 5(PDE 5) inhibitor developed for the treatment of erectile dysfunction(ED). Since ED is common in men with Diabetes Mellitus, it is important to determine the efficacy and safety of SK3530 on erectile dysfunction in Patients with Diabetes Mellitus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile dysfunction, Diabetes Mellitus, SK3530
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo as a substitute of SK3530 100mg
Intervention Type
Drug
Intervention Name(s)
SK3530
Other Intervention Name(s)
Mvix
Intervention Description
SK3530 100mg
Primary Outcome Measure Information:
Title
Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire
Time Frame
0, 4, 8, 12week
Secondary Outcome Measure Information:
Title
the score from : 1) IIEF Q3 & Q4, 2) other domains of IIEF, 3) Sexual Encounter Profile(SEP)Q2 and Q3, 4) Life Satisfaction Checklist, 5) Global Efficacy Assessment Question(GEAQ)
Time Frame
0, 4, 8, 12 week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of type 1 or type 2 diabetes.
Score below 25 from IIEF EF domain during 4 weeks of treatment run-in period.
Failure rate above 50% from sexual attempt above 4 during 4 weeks of treatment run-in period.
Exclusion Criteria:
Lab abnormality.
Uncontrolled diabetic mellitus(HbA1c > 12%).
High or low blood pressure, orthostatic hypotension.
Hyper- or hypo-thyroidism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Chul Park, MD, PhD
Organizational Affiliation
BNUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
SK Chemicals Co., Ltd
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus
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