Effects of Drospirenone-ethinylestradiol and/or NOMAC-valerate Estradiol on Cardiovascular Risk in Women With Polycystic Ovary Syndrome
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ClinicalTrials.gov Identifier: NCT01603745
Recruitment Status : Unknown
Verified May 2012 by Rosanna Apa, Catholic University of the Sacred Heart. Recruitment status was: Recruiting
First Posted : May 22, 2012
Last Update Posted : May 22, 2012
Catholic University of the Sacred Heart
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart
Polycystic ovary syndrome (PCOS) is often associated with pathological conditions, such as insulin resistance (IR), type 2 diabetes (DM2), obesity and it has potentially increased risk for cardiovascular disease (CVD). Of note, risk factors for CVD including dyslipidaemia, hypertension, oxidative stress and inflammation are associated with PCOS. The investigators want to evaluate the effects of two different types of E/P therapy on cardiovascular risk in PCOS.
Condition or disease
Polycystic Ovary Syndrome
Drug: ZoelyDrug: Yasmin
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.
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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 35 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
patients with PCOS aged 18-35 years
chronic or acute inflammatory disease
treatment with clomiphene citrate
drugs to control appetite or insulin-sensitizing drugs (metformin, pioglitazone and rosiglitazone) during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes)