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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00668252
Date of registration: 09/04/2008
Prospective Registration: No
Primary sponsor: Assistance Publique - Hôpitaux de Paris
Public title: Circulating Endothelium Progenitor Cells and Endogenous Oestrogen in Healthy Subjects Oestropec
Scientific title: Impact of Endogenous Sexual Hormones (Oestrogens and Testosterone) on the Endothelium Circulatory on Rolling at the Young and Old Healthy Volunteer.
Date of first enrolment: April 2006
Target sample size: 48
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00668252
Study type:  Observational
Study design:  Time Perspective: Cross-Sectional  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Tabassome Simon, MD - PhD
Address: 
Telephone:
Email:
Affiliation:  Assistance Publique Hopitaux de Paris - Université Pierre et Marie Curie Paris 6
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 79 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Healthy
Intervention(s)
Primary Outcome(s)
Number of endothelial progenitor cells by cytometry [Time Frame: Baseline]
Secondary Outcome(s)
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]
Secondary ID(s)
P050904
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Institut National de la Santé Et de la Recherche Médicale, France
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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