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Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus

Sponsor
SK Chemicals Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT00705861
Collaborator
(none)
112
Enrollment
1
Location
2
Arms
8
Duration (Months)
14
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 1

Drug: Placebo
Placebo as a substitute of SK3530 100mg
Experimental: 2

Drug: SK3530
SK3530 100mg
Other Names:
  • Mvix

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire [0, 4, 8, 12week]

    Secondary Outcome Measures

    1. 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) [0, 4, 8, 12 week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SK Chemicals Co., Ltd Seoul Korea, Republic of

    Sponsors and Collaborators

    • SK Chemicals Co., Ltd.

    Investigators

    • Principal Investigator: Nam-Chul Park, MD, PhD, BNUH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SK Chemicals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT00705861
    Other Study ID Numbers:
    • SK3530_DM_III
    First Posted:
    Jun 26, 2008
    Last Update Posted:
    Apr 18, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by SK Chemicals Co., Ltd.
    Erectile dysfunction
    Diabetes Mellitus
    SK3530
    Additional relevant MeSH terms:
    Erectile Dysfunction
    Diabetes Mellitus

    Study Results

    No Results Posted as of Apr 18, 2013