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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 24, 2008

Last Updated Date

June 25, 2008

Start Date ^†

November 2007

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00705861 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Erectile Dysfunction

Intervention ^†

Drug: Placebo
Drug: SK3530

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

112

Estimated Completion Date

November 2008

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

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.

Gender

Male

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Nam-Chul Park, MD, PhD

82-51-240-7349

pnc@pusna.ac.kr

Location Countries ^†

Korea, Republic of

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00705861

Responsible Party

Don-Yong Chang/SK Chemicals Co.,Ltd, SK Chemicals Co.,Ltd.

Secondary IDs ^††

Study Sponsor ^†

SK Chemicals Co.,Ltd.

Collaborators ^††

Investigators ^†

Principal Investigator:

Nam-Chul Park, MD, PhD

BNUH

Information Provided By

SK Chemicals Co.,Ltd.

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.