The Early Diagnosis and Warning Role of Erectile Dysfunction

Tracking Information
First Submitted Date	November 29, 2010
First Posted Date	November 30, 2010
Last Update Posted Date	November 30, 2010
Study Start Date	January 2008
Actual Primary Completion Date	October 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	The Early Diagnosis and Warning Role of Erectile Dysfunction
Official Title	The Early Diagnosis and Warning Role of Erectile Dysfunction:a Multi-institutional Clinical Study.
Brief Summary	Find the early diagnostic markers of erectile dysfunction;; Study the warning role of ED in some diseases.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Case Control
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	men with erectile dysfunction healthy men general male population
Condition	Erectile Dysfunction; Endothelial Dysfunction
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Recruiting
Estimated Enrollment; (submitted: November 29, 2010)	150000
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	January 2020
Actual Primary Completion Date	October 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Male and at least 18 years of age.; Provide signed informed consent.; Have a history of erectile dysfunction (ED: defined as a consistent change in the quality of erection that adversely affects the subject's satisfaction with sexual intercourse) .; Have a stable monogamous relationship with a female partner. To some subjects with poor sexual experience, re-evaluation would be conducted after a 4-weeks sex education.; Make at least four sexual intercourse attempts with the female sexual study partner during the 4-week therapeutic period without medication.; Agree not to use any other ED treatment for at least 4 weeks. Exclusion Criteria: severe diseases (such as congestive heart failure, arrhythmia, significant renal or hepatic dysfunction and anemia);; Had clinically noteworthy penile deformities, pelvic surgery or trauma of perineal region;; Had received long-term pharmacotherapy (including antioxidant agents, vitamins and traditional Chinese drugs).; An addiction problem (with a history of injection or administration of opium, poppy, heroin, hemp, morphine, cocaine, caffeine, ketamine and meperidine etc.)
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts	Contact: Chunhua Deng, MD, PhD (01186)20-87333300 dch0313@163.com Contact: Yanping Huang, MD (01186)20-87333300 hyppin@gmail.com
Listed Location Countries	China
Removed Location Countries
Administrative Information
NCT Number	NCT01249703
Other Study ID Numbers	Chunhua Deng
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Chunhua Deng, Department of Urology
Study Sponsor	Sun Yat-sen University
Collaborators	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators	Principal Investigator: Chunhua Deng, MD, PhD Department of Urology
PRS Account	Sun Yat-sen University
Verification Date	January 2008