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Retrograde Ejaculation and Sexual Dysfunction in Men With Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01743599
First Posted: December 6, 2012
Last Update Posted: October 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jens Fedder, Odense University Hospital
  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

Further study details as provided by Jens Fedder, 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. ]

Secondary Outcome Measures:
  • Erectile dysfunction [ Time Frame: The examination program (including a questionaire on erectile dysfunction) for each patient was finished within one day. ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743599


Locations
Denmark
Fertility Clinic, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
  More Information

Publications:
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
First Submitted: November 27, 2012
First Posted: December 6, 2012
Last Update Posted: October 4, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases