Circulating Endothelium Progenitor Cells and Endogenous Oestrogen in Healthy Subjects

Completed

• Conditions: Healthy

• Registration Number: NCT00668252
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed Description

Study design: Open pilot study in health volunteers in the Hospital Saint-ANTOINE's Clinical Investigation Centre (CIC).

Recruitment and course of the study: The subjects will be recruited among the CIC's pool of healthy volunteers. Volunteer people will then have biological and clinical baseline examinations. If they match the inclusion criteria, an appointment will be taken for the blood sample intend for the characterization of the EPC and hormonal plasma levels evaluation. The participation will not exceed 2 months. Young women will have to come between the 9th and the 11th day after the beginning of menses). A total of 150 ml of peripheral blood will be collected. The study will last 18 months.

Study Timeline

• Status Verified: 2006-03
• Study Start: 2006-04
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Study First Submitted: 2008-04-09
• Study First Submitted QC: 2008-04-28
• Last Update Submitted: 2008-04-28
• Study First Posted: 2008-04-29
• Last Update Posted: 2008-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of endothelial progenitor cells by cytometry	Baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Paris - Hopital Saint Antoine; 🇫🇷 Paris, France