Polycystic Ovary Syndrome Clinical Trial
To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS patients
Polycystic ovary syndrome (PCOS), one of the most common endocrine disorders affecting women on reproductive age , seems to be associated with an increased incidence of cardiovascular disease. At present, insulin-sensitizing drugs, such as metformin, represent one of the most important line treatment for hyperinsulinemic PCOS women. Metformin is able to produce favourable outcomes on the metabolic derangements in insulin-resistant normal weight and obese PCOS patients. Oral contraceptives represent the traditional medical therapy for the long-term treatment of PCOS women, in order to obtain regular menstrual cycles and to improve the clinical signs of hyperandrogenism.Based on the above mentioned evidences, the aim of the present study was 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 patients ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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