The Early Diagnosis and Warning Role of Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

The Early Diagnosis and Warning Role of Erectile Dysfunction:a Multi-institutional Clinical Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01249703
• Other study ID #: Chunhua Deng
• Status: Recruiting
• Phase: N/A
• First received: November 29, 2010
• Last updated: November 29, 2010
• Start date: January 2008
• Est. completion date: January 2020

Study information

• Verified date: January 2008
• Source: Sun Yat-sen University
• Contact: Chunhua Deng, MD, PhD
• Phone: (01186)20-87333300
• Email: dch0313[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

1. Find the early diagnostic markers of erectile dysfunction;

2. Study the warning role of ED in some diseases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150000
• Est. completion date: January 2020
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male and at least 18 years of age.

2. Provide signed informed consent.

3. 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) .

4. 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.

5. Make at least four sexual intercourse attempts with the female sexual study partner during the 4-week therapeutic period without medication.

6. Agree not to use any other ED treatment for at least 4 weeks.

Exclusion Criteria:

1. severe diseases (such as congestive heart failure, arrhythmia, significant renal or hepatic dysfunction and anemia);

2. Had clinically noteworthy penile deformities, pelvic surgery or trauma of perineal region;

3. Had received long-term pharmacotherapy (including antioxidant agents, vitamins and traditional Chinese drugs).

4. An addiction problem (with a history of injection or administration of opium, poppy, heroin, hemp, morphine, cocaine, caffeine, ketamine and meperidine etc.)

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Erectile Dysfunction

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guang Dong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China,