Status:
COMPLETED
Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Erectile Dysfunction
Eligibility:
MALE
19+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- Lab abnormality.
- Uncontrolled diabetic mellitus(HbA1c \> 12%).
- High or low blood pressure, orthostatic hypotension.
- Hyper- or hypo-thyroidism.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00705861
Start Date
November 1 2007
End Date
July 1 2008
Last Update
April 18 2013
Active Locations (1)
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1
SK Chemicals Co., Ltd
Seoul, South Korea