Erectile DysfunctionNCT01249703
The Early Diagnosis and Warning Role of Erectile Dysfunction
An observational study of Erectile Dysfunction and Endothelial Dysfunction, run by Sun Yat-sen University at 1 site in China.
Trial summary
1. Find the early diagnostic markers of erectile dysfunction; 2. Study the warning role of ED in some diseases. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Endothelial Dysfunction
- How many people
- 150,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: men with erectile dysfunction healthy men general male population
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Chunhua Deng, MD, PhD, (01186) 20-87333300, dch0313@163.com
Yanping Huang, MD, (01186) 20-87333300, hyppin@gmail.com
About this study
Official title: The Early Diagnosis and Warning Role of Erectile Dysfunction:a Multi-institutional Clinical Study.
- Find the early diagnostic markers of erectile dysfunction;
- Study the warning role of ED in some diseases.
- Conditions
- Erectile Dysfunction, Endothelial Dysfunction
- Medical subject headings
- Erectile Dysfunction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startJan 2008
- Primary completionOct 2010
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Chunhua Deng, MD, PhD, Principal investigator, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249703
- Sponsor's protocol ID
- Chunhua Deng
- Status last verified
- Jan 2008
- First submitted
- 29 Nov 2010
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Diagnosis and Warning Role of Erectile Dysfunction:a Multi-institutional Clinical Study.
- ClinicalTrials.gov ID
- NCT01249703
- Acronym / sponsor ID
- Chunhua Deng
- Conditions
- Erectile Dysfunction, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- Jan 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2020 (estimated)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Find the early diagnostic markers of erectile dysfunction;
- Study the warning role of ED in some diseases.
Study design
- Observational model
- Case-control
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- men with erectile dysfunction healthy men general male population
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunhua Deng, MD, PhD principal investigator
Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction and Endothelial Dysfunction, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunhua Deng, MD, PhD ((01186)20-87333300, dch0313@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2010.