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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00705861
First received: June 24, 2008
Last updated: April 16, 2013
Last verified: April 2013

June 24, 2008
April 16, 2013
November 2007
July 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00705861 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus
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

The purpose of this study is to evaluate the efficacy and safety of SK3530 on erectile dysfunction in Patients with Diabetes Mellitus.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Erectile Dysfunction
  • Drug: Placebo
    Placebo as a substitute of SK3530 100mg
    Other Name: placebo
  • Drug: SK3530
    SK3530 100mg
    Other Name: Mvix
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: 2
    Intervention: Drug: SK3530
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Male
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00705861
SK3530_DM_III
Yes
SK Chemicals Co.,Ltd.
SK Chemicals Co.,Ltd.
Not Provided
Principal Investigator: Nam-Chul Park, MD, PhD BNUH
SK Chemicals Co.,Ltd.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP