Circulating Endothelium Progenitor Cells and Endogenous O... | NCT00668252

Studies
Circulating Endothelium Progenitor Cells and Endogenous Oestrogen in Healthy Subjects

NCT00668252

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Apr 29, 2008Estimated

Enrollment

48Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Apr 9, 2008

First Submission Date that Met QC Criteria

Apr 28, 2008

First Posted Date

Apr 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2008

Last Update Posted Date

Apr 29, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Non menopausal women
2		age matched men
3		Menopausal women
4		age matched men

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of endothelial progenitor cells by cytometry		Baseline

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tabassome Simon, MD - PhD	Assistance Publique Hopitaux de Paris - Université Pierre et Marie Curie Paris 6	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hopitaux de Paris - Hopital Saint Antoine		Paris		75012	France