NCT00705861

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2008

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

8 months

First QC Date

June 24, 2008

Last Update Submit

April 16, 2013

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunctionDiabetes MellitusSK3530

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: Placebo

2

EXPERIMENTAL
Drug: SK3530

Interventions

PlaceboDRUG

Placebo as a substitute of SK3530 100mg

1
SK3530DRUG

SK3530 100mg

Also known as: Mvix
2

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Lab abnormality.
  • Uncontrolled diabetic mellitus(HbA1c \> 12%).
  • High or low blood pressure, orthostatic hypotension.
  • Hyper- or hypo-thyroidism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SK Chemicals Co., Ltd

Seoul, South Korea

Location

MeSH Terms

Conditions

Erectile DysfunctionDiabetes Mellitus

Interventions

2-(5-(4-(2-hydroxyethyl)piperazin-1-ylsulfonyl)-2-n-propoxyphenyl)-5-ethyl-7-n-propyl-3,5-dihydro-4H-pyrrolo(3,2-d)pyrimidin-4-one dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nam-Chul Park, MD, PhD

    BNUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2008

First Posted

June 26, 2008

Study Start

November 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

April 18, 2013

Record last verified: 2013-04

Locations

KR(1)