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Completed

NCT Number: NCT00668252

Circulating Endothelium Progenitor Cells and Endogenous Oestrogen in Healthy Subjects

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

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Key information

Conditions

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hopitaux de Paris - Hopital Saint Antoine

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of endothelial progenitor cells by cytometry

    Time frame: 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.

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Impact of Endogenous Sexual Hormones (Oestrogens and Testosterone) on the Endothelium Circulatory on Rolling at the Young and Old Healthy Volunteer.

Acronym: Oestropec

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 29, 2008
Registry last updated
Apr 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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