Erectile DysfunctionNCT00282477
Trial to Evaluate Erectile Function, Fertility and Sperm Count in Male Cyclists Compared to Age Matched Controls
An observational study of Erectile Dysfunction and Azoospermia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Bicycle riding is associated with related diverse urogenital symptoms ranging from genital numbness to erectile dysfunction (ED). Very little is known about the quality of sperm in cyclists and whether a connection exists between erectile dysfunction and azoospermia. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Azoospermia
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2006to not given
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males ages 20-35, with at least 2 years of bicycle riding, at least 2 hours a week.
Who cannot join
- History of prostatic surgery, testicular surgery, or single testis,
- Patients after chemotherapy,
- Patients receiving hormonal therapy,
- Patients receiving alpha blockers for any indication.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Chaim Sheba Medical Center
Ramat Gan, 5261
Uri A. Lindner, M.D
About this study
Official title: Prospective Controlled Trial to Evaluate Erectile Function, Fertility and Sperm Count in Male Cyclists Compared to Age Matched Controls
Bicycle riding is associated with related diverse urogenital symptoms ranging from genital numbness to erectile dysfunction (ED). Very little is known about the quality of sperm in cyclists and whether a connection exists between erectile dysfunction and azoospermia.
- Conditions
- Erectile Dysfunction, Azoospermia
- Keywords
- cyclist
- Medical subject headings
- Erectile Dysfunction, Azoospermia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2006 (estimated)
- Study startFeb 2006
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.
- 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
- Defined population
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Igael Madgar, M.D, Principal investigator, Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282477
- Sponsor's protocol ID
- SHEBA-05-4031-IM-CTIL
- Status last verified
- Aug 2007
- First submitted
- 25 Jan 2006
- Last updated
- 7 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Trial to Evaluate Erectile Function, Fertility and Sperm Count in Male Cyclists Compared to Age Matched Controls
- ClinicalTrials.gov ID
- NCT00282477
- Acronym / sponsor ID
- SHEBA-05-4031-IM-CTIL
- Conditions
- Erectile Dysfunction, Azoospermia
- Keywords
- cyclist
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Feb 2006
- First posted
- 26 Jan 2006 (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.
Bicycle riding is associated with related diverse urogenital symptoms ranging from genital numbness to erectile dysfunction (ED). Very little is known about the quality of sperm in cyclists and whether a connection exists between erectile dysfunction and azoospermia.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males ages 20-35, with at least 2 years of bicycle riding, at least 2 hours a week.
Key exclusion criteria (4 listed)
- History of prostatic surgery, testicular surgery, or single testis,
- Patients after chemotherapy,
- Patients receiving hormonal therapy,
- Patients receiving alpha blockers for any indication.
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 7 Aug 2007.
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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.
Igael Madgar, M.D principal investigator
Chaim Sheba Medical Center
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 Azoospermia, run by Sheba Medical Center at 1 site in Israel.
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 1 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 7 Aug 2007. 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 Israel. 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 Uri A. Lindner, M.D (972-3-5302413, Uri.Lindner@Sheba.health.gov.il), 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 7 Aug 2007.