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

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Healthy

Study type

Observational

Funder types

Other

Identifiers

NCT00668252
P050904

Details and patient eligibility

About

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

Full 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.

Enrollment

48 patients

Sex

All

Ages

18 to 79 years old

Volunteers

Accepts 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.

Trial design

48 participants in 4 patient groups

1
Description:
Non menopausal women
2
Description:
age matched men
3
Description:
Menopausal women
4
Description:
age matched men

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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