Retrograde Ejaculation and Sexual Dysfunction in Men With Diabetes Mellitus

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743599

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

No publications provided by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014