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

Sponsored by:	SK Chemicals Co.,Ltd.
Information provided by:	SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT00705861

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 III

MedlinePlus related topics: Diabetes Erectile Dysfunction

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	112
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo Placebo as a substitute of SK3530 100mg
2: Experimental	Drug: SK3530 SK3530 100mg

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

Contacts

Contact: Nam-Chul Park, MD, PhD

82-51-240-7349

pnc@pusna.ac.kr

Locations

Korea, Republic of
SK Chemicals Co., Ltd	Recruiting
Seoul, Korea, Republic of
Principal Investigator: Nam-Chul Park, MD, PhD

Sponsors and Collaborators

SK Chemicals Co.,Ltd.

Investigators

Principal Investigator:

Nam-Chul Park, MD, PhD

BNUH

More Information

Responsible Party:	SK Chemicals Co.,Ltd. ( Don-Yong Chang/SK Chemicals Co.,Ltd )
Study ID Numbers:	SK3530_DM_III
Study First Received:	June 24, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00705861
Health Authority:	Korea: Food and Drug Administration

Keywords provided by SK Chemicals Co.,Ltd.:

Erectile dysfunction
Diabetes Mellitus
SK3530

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Metabolic Diseases
Mental Disorders
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Genital Diseases, Male
Glucose Metabolism Disorders
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual and Gender Disorders

ClinicalTrials.gov processed this record on January 16, 2009