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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705861
• Other study ID #: SK3530_DM_III
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2008
• Last updated: April 16, 2013
• Start date: November 2007
• Est. completion date: July 2008

Study information

• Verified date: April 2013
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Erectile Dysfunction

Intervention

Drug:
• Placebo
Placebo as a substitute of SK3530 100mg
• SK3530
SK3530 100mg

Locations

Country	Name	City	State
Korea, Republic of	SK Chemicals Co., Ltd	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes