NCT01830049

Brief Summary

Erectile dysfunction (ED) is strongly associated with aging. With the rapidly expanding aging population and the increase in life expectancy, an increase in the prevalence of ED is expected in the years to come. Currently, the mechanism of ED is not fully understood. MicroRNAs (MiRNA) are endogenous small RNA molecules that control gene expression post-transcriptionally. It has been included in many in vitro physiology and pathophysiology processes, which also involved in the process of ED. This research was designed to investigate the differential plasma MiRNA profiles in ED and normal erectile function in older males. The results might tell us which MiRNA and how did it involved in the process of ED in aging.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

4 months

First QC Date

April 9, 2013

Last Update Submit

April 10, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gene chips

    30 days

Secondary Outcomes (1)

  • RT-PCR

    15 days

Study Arms (3)

Group I

Older males with ED

Other: Take blood

Group II

Older males with normal erectile function

Other: Take blood

Gourp III

Young males with normal rectile function

Other: Take blood

Interventions

Gourp IIIGroup IGroup II

Eligibility Criteria

Age20 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Group I: older males came to our clinic for diagnosis and treatment of ED. Group II: older males came to our clinic for physical examination and the erectile function was normal. Group III: young males came to our clinic for physical examination and the erectile function was normal.

You may qualify if:

  • older males with erectile dysfunction

You may not qualify if:

  • have some other general diseases, e.g. hypertension, vascular diseases, depression, chronic kidney disease, diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Gulou Hospital affiliated to Nanjing University, Medical School

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 11, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations