NCT01743599

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

3.2 years

First QC Date

November 27, 2012

Last Update Submit

October 3, 2016

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Erectile dysfunction

    The examination program (including a questionaire on erectile dysfunction) for each patient was finished within one day.

Study Arms (2)

Diabetic men

Non-diabetic men

Eligibility Criteria

Age30 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Diabetic men and non-diabetic men in Denmark.

You may qualify if:

  • Men 30-55 years of age
  • Men registered in a Diabetic Biobank including 6000 diabetics and 6000 controls

You may not qualify if:

  • Men who do not understand Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Clinic, Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 23606485RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Consultant, Ph.D.

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 6, 2012

Study Start

February 1, 2008

Primary Completion

April 1, 2011

Last Updated

October 4, 2016

Record last verified: 2016-10

Locations

DK(1)