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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00705861

Enrollment

112

Registered

2008-06-26

Start date

2007-11-30

Completion date

2008-07-31

Last updated

2013-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction, Diabetes Mellitus, SK3530

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.

Interventions

DRUGPlacebo

Placebo as a substitute of SK3530 100mg

DRUGSK3530

SK3530 100mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire	0, 4, 8, 12week

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026