Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus
NCT ID: NCT00705861
Last Updated: 2013-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
112 participants
INTERVENTIONAL
2007-11-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Placebo
Placebo as a substitute of SK3530 100mg
2
SK3530
SK3530 100mg
Interventions
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Placebo
Placebo as a substitute of SK3530 100mg
SK3530
SK3530 100mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Uncontrolled diabetic mellitus(HbA1c \> 12%).
* High or low blood pressure, orthostatic hypotension.
* Hyper- or hypo-thyroidism.
19 Years
MALE
No
Sponsors
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SK Chemicals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Nam-Chul Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
BNUH
Locations
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SK Chemicals Co., Ltd
Seoul, , South Korea
Countries
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Other Identifiers
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SK3530_DM_III
Identifier Type: -
Identifier Source: org_study_id
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