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

SK chemicals

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

Treatments: Drug: Placebo; Drug: SK3530

Study type: Interventional

Funder types: Industry

Identifiers

NCT00705861

SK3530_DM_III

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 patients

Sex: Male

Ages: 19+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

112 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Placebo

2

Experimental group

Treatment:

Drug: SK3530