NCT00607282

Brief Summary

The purpose of this study is to evaluate the efficacy of Udenafil (Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in treatment of erectile dysfunction after radical resection for sigmoid colon and rectal cancer. In this study, the efficacy of Udenafil will be evaluated in treatment for patient with chronic erectile dysfunction, which developed after radical resection for sigmoid and rectal cancer and continues 12 months after the surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2009

Typical duration for phase_2

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

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

2.8 years

First QC Date

January 22, 2008

Last Update Submit

September 2, 2012

Conditions

Erectile DysfunctionSigmoid Colon CancerRectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Improvement of erectile function using IIEF-5 (International Index of Erectile Function-5), SEP Q2, Q3 (Sexual Encounter Profile Q2,Q3), and GEQ (Global efficacy Question)

    at 4 weeks after enrollment

Secondary Outcomes (1)

  • Improvement of erectile function using IIEF-5, SEP Q2,Q3, and GEQ

    at 12 months after enrollment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

normal control group

Drug: Udenafil

Udenafil

EXPERIMENTAL

oral administration of placebo for Udenafil (Dong-A Pharmaceutical co., Ltd, Seoul, Korea)

Drug: Udenafil

Interventions

UdenafilDRUG

oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months)

Also known as: Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea
PlaceboUdenafil

Eligibility Criteria

Age19 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients between 19-70 years old in good general health
  • Patient willing to treat postoperative erectile dysfunction and participate in the study
  • Patient who understands and accepts to sign the informed consent form
  • Patient who received radical resection for sigmoid colon and rectal cancer. : erectile dysfunction was developed following operation, not preoperatively
  • Scores of IIEF-5 measured at 12 months after surgery is 16 or less

You may not qualify if:

  • Documented problem of preoperative erectile dysfunction
  • Past history of myocardial infarction, cerebrovascular disease
  • Under administration of nitrate
  • Liver dysfunction (SGOT or SGPT 100 IU/L or more)
  • Kidney dysfunction (serum Creatinine 3mg/dl or more)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

MeSH Terms

Conditions

Erectile DysfunctionSigmoid NeoplasmsRectal Neoplasms

Interventions

udenafilLong-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersColonic NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesSigmoid DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Neuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sung-Bum Kang, M.D., Ph.D

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

March 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

KR(1)