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

S

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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