Retrograde Ejaculation and Sexual Dysfunction in Men With Diabetes Mellitus
This study has been completed.
Sponsor:
Odense University Hospital
Information provided by (Responsible Party):
Jens Fedder, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01743599
First received: November 27, 2012
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
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.
| Condition |
|---|
|
Diabetes Mellitus |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by Odense University Hospital:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Erectile dysfunction [ Time Frame: The examination program (including a questionaire on erectile dysfunction) for each patient was finished within one day. ] [ Designated as safety issue: No ]
| Enrollment: | 45 |
| Study Start Date: | February 2008 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Diabetic men |
| Non-diabetic men |
Eligibility| Ages Eligible for Study: | 30 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Diabetic men and non-diabetic men in Denmark.
Criteria
Inclusion Criteria:
- Men 30-55 years of age
- Men registered in a Diabetic Biobank including 6000 diabetics and 6000 controls
Exclusion Criteria:
- Men who do not understand Danish
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jens Fedder, Professor, Consultant, Ph.D., Odense University Hospital |
| ClinicalTrials.gov Identifier: | NCT01743599 History of Changes |
| Other Study ID Numbers: | Lab.Reprod.Biol.-Horsens-01 |
| Study First Received: | November 27, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | Denmark: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013