PCOS is the most common female endocrinopathy in reproductive age. This syndrome is a
heterogeneous condition characterized by several symptoms and clinical signs related to
reproductive, cardiometabolic and psychological disorders.We recently demonstrated that
young PCOS women show an expansion of an unusual T-cell population with proinflammatory
functions, identified by CD4+CD28null T lymphocytes . Of note, this T subpopulation has been
found to be expanded in patients with unstable angina, type 2 diabetes (DM2), in absence of
clinical evidence of CVD 12, and has been recently associated to recurrent coronary
instability .Based on the above mentioned evidences, the aim of the present study is to
evaluate the effects of DRPS/EE alone versus metformin alone versus DRPS/EE plus metformin
on the CD4+CD28null T cells frequency and on endocrino-metabolic parameters, in
hyperinsulinemic PCOS patientsTo evaluate long-term effects of drospirenone
(DRSP)/ethinylestradiol (EE) and NOMAC-valerate estardiol on some cardiovascular risk
factors in PCOS patients.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
cardiovascular risk
total testosterone (T), SHBG, androstenedione (A), 17-hydroxyprogesterone (17-OHP), dehydroepiandrosterone sulphate (DHEAS), triglycerides, total cholesterol, high- and low-density lipoprotein cholesterol (HDL and LDL cholesterol) and alanine aminotransferase (ALT),CD4+CD28null frequency
120 minutes
Yes
Italy: National Institute of Health
zoely1984
NCT01603745
April 2012
October 2012
Name | Location |
---|