Diabetes MellitusNCT01743599
Retrograde Ejaculation and Sexual Dysfunction in Men With Diabetes Mellitus
An observational study of Diabetes Mellitus, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Diabetic men and controls are examined for retrograde ejaculation, and erectile dysfunction is registered with a validated questionaire (International Index of Erectile Function-15). Concentration, total number of sperm and motility is determined in freshly delivered ejaculates and postejaculatory urine. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men only
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to Apr 2011
- 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 30 to 55 years
- Men only
- No healthy volunteers
- Adult
Study population: Diabetic men and non-diabetic men in Denmark.
Who may be able to join
- Men 30-55 years of age
- Men registered in a Diabetic Biobank including 6000 diabetics and 6000 controls
Who cannot join
- Men who do not understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
Diabetic men and controls are examined for retrograde ejaculation, and erectile dysfunction is registered with a validated questionaire (International Index of Erectile Function-15). Concentration, total number of sperm and motility is determined in freshly delivered ejaculates and postejaculatory urine. Our hypothetis is that diabetics exhibit significantly higher rate of retrograde ejaculation than healthy controls.
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic men | Not described | |
| Non-diabetic men | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrograde ejaculation (a minimum of a total of 1 million sperm in postejaculatory urine)
Measured: The examination program for each patient was finished within one day.
Secondary outcomes (1)
Erectile dysfunction
Measured: The examination program (including a questionaire on erectile dysfunction) for each patient was finished within one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startFeb 2008
- Primary completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Fedder, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743599
- Sponsor's protocol ID
- Lab.Reprod.Biol.-Horsens-01
- Status last verified
- Oct 2016
- First submitted
- 27 Nov 2012
- Last updated
- 4 Oct 2016
- Results posted
- No
Publications
Fedder J, Kaspersen MD, Brandslund I, Hojgaard A. Retrograde ejaculation and sexual dysfunction in men with diabetes mellitus: a prospective, controlled study. Andrology. 2013 Jul;1(4):602-6. doi: 10.1111/j.2047-2927.2013.00083.x. Epub 2013 Apr 18.
PubMed 23606485
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde Ejaculation and Sexual Dysfunction in Men With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01743599
- Acronym / sponsor ID
- Lab.Reprod.Biol.-Horsens-01
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2011 (actual)
- First posted
- 6 Dec 2012 (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.
Diabetic men and controls are examined for retrograde ejaculation, and erectile dysfunction is registered with a validated questionaire (International Index of Erectile Function-15). Concentration, total number of sperm and motility is determined in freshly delivered ejaculates and postejaculatory urine. Our hypothetis is that diabetics exhibit significantly higher rate of retrograde ejaculation than healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic men | – | – |
| Non-diabetic men | – | – |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Diabetic men and non-diabetic men in Denmark.
Key inclusion criteria (2 listed)
- Men 30-55 years of age
- Men registered in a Diabetic Biobank including 6000 diabetics and 6000 controls
Key exclusion criteria (1 listed)
- Men who do not understand Danish
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
Retrograde ejaculation (a minimum of a total of 1 million sperm in postejaculatory urine)
Time frame: The examination program for each patient was finished within one day.
1 secondary outcome
Erectile dysfunction
Time frame: The examination program (including a questionaire on erectile dysfunction) for each patient was finished within one day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Results publication: PubMed 23606485Fedder J, Kaspersen MD, Brandslund I, Hojgaard A. Retrograde ejaculation and sexual dysfunction in men with diabetes mellitus: a prospective, controlled study. Andrology. 2013 Jul;1(4):602-6. doi: 10.1111/j.2047-2927.2013.00083.x. Epub 2013 Apr 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetes Mellitus, run by Odense University Hospital at 1 site in Denmark.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 4 Oct 2016. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrograde ejaculation (a minimum of a total of 1 million sperm in postejaculatory urine) (time frame: The examination program for each patient was finished within one day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01743599, which also lists 1 linked publication.
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 4 Oct 2016.