Female steroid hormones and protection from cardiovascular risk: staminal endothelial progenitor cells and menopause. - ND

• Conditions: Postmenopause; MedDRA version: 9.1Level: LLTClassification code 10051775Term: Postmenopause

• Registration Number: EUCTR2007-006082-32-IT
• Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

a) regular menstrual cycles; b) presence of both ovaries; c) surgical procedure of bilateral annessiectomy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a) treatment with estrogens, estroprogestins or GnRH analogues in previous 3 months; b) oligoamenorrhoea; c) hypertension; d) diabetes mellitus; e) smoke; f) hyperlipidemia; g) obesity; h) positive medical history of cardiovascular diseases; i) positive medical history of malignant diseases; renal insufficiency, cerebrovascular diseases; l) therapy with statins, low-dose aspirin and erythropoietin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine correlation between levels of circulating endothelial progenitor cells (EPCs) and estrogens, in women of fertile age and in postmenopause.;Secondary Objective: Assess plasmatic levels of LH, FSH, estradiol, sex hormone binding globulin and hemochrome for evaluating absolute number of EPCs.;Primary end point(s): Assess levels of endothelial progenitor cells (EPCs) before and after removal of ovaries and in case after estrogens substitutive therapy, in women of fertile age submitted to surgical ovariectomy.