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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Chemicals Co., Ltd.; SK Chemicals Co.,Ltd.

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.