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Clinical Trials/NCT00705861
NCT00705861CompletedPhase 3

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

SK Chemicals Co., Ltd.1 site in 1 country112 target enrollmentStarted: November 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
112
Locations
1
Primary Endpoint
Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
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.

Arms & Interventions

1

Placebo Comparator

Intervention: Placebo (Drug)

2

Experimental

Intervention: SK3530 (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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