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

SK Chemicals Co., Ltd.112 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

112

Conditions

Erectile Dysfunction

Interventions

PlaceboDRUG

Placebo as a substitute of SK3530 100mg

SK3530DRUG

SK3530 100mg

Eligibility

Sex: MALEMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

SK Chemicals Co., Ltd

Seoul, South Korea

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)

Time frame: 0, 4, 8, 12 week

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.