NCT00668252

Brief Summary

The purpose of this study is to determine whether the number of circulating EPC is different between healthy women and men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2006

Shorter than P25 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

April 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 9, 2008

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
Last Updated

April 29, 2008

Status Verified

March 1, 2006

Enrollment Period

1 year

First QC Date

April 9, 2008

Last Update Submit

April 28, 2008

Conditions

Keywords

endothelial progenitor cellsestrogenmenopausecardiovascular risk

Outcome Measures

Primary Outcomes (1)

  • Number of endothelial progenitor cells by cytometry

    Baseline

Secondary Outcomes (1)

  • To compare the number of EPC in young women to older men and menopausal women. To evaluate the correlation between the number of EPC and 17 b-estradiol plasma level.

    Baseline

Study Arms (4)

1

Non menopausal women

2

age matched men

3

Menopausal women

4

age matched men

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • BMI between 19 and 25 kg/m²
  • non menopausal women :
  • age 18 to 40 years,
  • regular menstrual cycles
  • no hormone therapy as contraceptives
  • postmenopausal women :
  • age above 55 years old
  • amenorrhoea since 5 years at least
  • no hormone therapy since at least 3 month

You may not qualify if:

  • no medical insurance
  • smoking, Statins treatment, uncontrolled diabetes or hypertension and personal history of cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Paris - Hopital Saint Antoine

Paris, 75012, France

Location

Biospecimen

Retention: NONE RETAINED

whole peripheral blood (150 ml)

Study Officials

  • Tabassome Simon, MD - PhD

    Assistance Publique Hopitaux de Paris - Université Pierre et Marie Curie Paris 6

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2008

First Posted

April 29, 2008

Study Start

April 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

April 29, 2008

Record last verified: 2006-03

Locations