Circulating Endothelium Progenitor Cells and Endogenous Oestrogen in Healthy Subjects (Oestropec)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00668252
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : April 29, 2008
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
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.

Condition or disease

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 Type : Observational
Actual Enrollment : 48 participants
Time Perspective: Cross-Sectional
Official Title: Impact of Endogenous Sexual Hormones (Oestrogens and Testosterone) on the Endothelium Circulatory on Rolling at the Young and Old Healthy Volunteer.
Study Start Date : April 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens
U.S. FDA Resources

Non menopausal women
age matched men
Menopausal women
age matched men

Primary Outcome Measures :
  1. Number of endothelial progenitor cells by cytometry [ Time Frame: Baseline ]

Secondary Outcome Measures :
  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. [ Time Frame: Baseline ]

Biospecimen Retention:   None Retained
whole peripheral blood (150 ml)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00668252

Assistance Publique Hopitaux de Paris - Hopital Saint Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Tabassome Simon, MD - PhD Assistance Publique Hopitaux de Paris - Université Pierre et Marie Curie Paris 6

Responsible Party: Yannick Vacher, Department Clinical Research of Developpement Identifier: NCT00668252     History of Changes
Other Study ID Numbers: P050904
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: April 29, 2008
Last Verified: March 2006

Keywords provided by Assistance Publique - Hôpitaux de Paris:
endothelial progenitor cells
cardiovascular risk

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs