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NCT01743599 Clinical Trial

Retrograde Ejaculation and Sexual Dysfunction in Men With Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01743599
Other study ID # Lab.Reprod.Biol.-Horsens-01
Secondary ID
Status Completed
Phase N/A
First received November 27, 2012
Last updated October 3, 2016
Start date February 2008

Study information
Verified date October 2016
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Institutional Review Board
Study type Observational

Clinical 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. Our hypothetis is that diabetics exhibit significantly higher rate of retrograde ejaculation than healthy controls.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Male
Age group 30 Years to 55 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Fertility Clinic, Odense University Hospital Odense

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Fedder J, Kaspersen MD, Brandslund I, Højgaard 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Retrograde ejaculation (a minimum of a total of 1 million sperm in postejaculatory urine) The examination program for each patient was finished within one day. No
Secondary Erectile dysfunction The examination program (including a questionaire on erectile dysfunction) for each patient was finished within one day. No
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