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
  Purpose

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


Condition Intervention Phase
Erectile Dysfunction
Drug: Placebo
Drug: SK3530
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by SK Chemicals Co.,Ltd.:

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 [ Time Frame: 0, 4, 8, 12week ] [ Designated as safety issue: Yes ]

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) [ Time Frame: 0, 4, 8, 12 week ] [ Designated as safety issue: Yes ]

Enrollment: 112
Study Start Date: November 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Placebo as a substitute of SK3530 100mg
Other Name: placebo
Experimental: 2 Drug: SK3530
SK3530 100mg
Other Name: Mvix

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705861

Locations
Korea, Republic of
SK Chemicals Co., Ltd
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Investigators
Principal Investigator: Nam-Chul Park, MD, PhD BNUH
  More Information

No publications provided

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00705861     History of Changes
Other Study ID Numbers: SK3530_DM_III
Study First Received: June 24, 2008
Last Updated: April 16, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by SK Chemicals Co.,Ltd.:
Erectile dysfunction
Diabetes Mellitus
SK3530

Additional relevant MeSH terms:
Diabetes Mellitus
Erectile Dysfunction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014