Comparison of the metabolic and hormonal effects of two oral contraceptives in women with polycystic ovary syndrome (PCOS) for a period of two years follow-up.

INTERVENTION: 120 subjects were randomized into two groups. Group A received ethinyl estradiol 0.03 mg + Drospirenone 3mg (EE+DRSP; n=60) and Group B received ethinyl estradiol 0.03 mg+Chlormadinone acetate 2 mg (EE+CMA; n=60). In Group A, one patient at 6 months, two patients at 12 months discontinued the treatment. At 24 months one patient was lost to follow up and 56 subjects completed the study. In Group B, two patients at 6 months, two patients at 12 months and three patients at 24 months discontinued the treatment. One patient at 12 months, two patients at 24 months were lost to follow up and 50 subjects completed the study. Thus analyses were performed for 56 subjects in group A and 50 subjects in Group B.All subjects were advised to take the oral tablets once daily and with appropriate instructions cyclically ( 21 pill intake days followed by 7 pill free days) for 24 months. Oral tablet return was checked every 3 months to monitor adherence. Clinical, hormonal and biochemical parameters were compared at baseline, 6 months, 12 months and 24 months. CONDITION: Contraception Polycystic ovary syndrome PRIMARY OUTCOME: free androgen index (FAI) ; Free androjen index (FAI) was calculated by the formula, ; FAI = (Total testesterone nmol/L) / sex hormone‐binding globulin nmol/L) x 100. ; total testesterone and sex hormone‐binding globulin levels were determined by serum assay. Insulin resistance, defined by the homeostasis model assessment insulin resistance index (HOMA‐IR), which was calculated using the following equation: HOMA‐IR = fasting insulin (microU/L) x fasting glucose (mmol/L)/22.5 ; fasting insulin and glucose levels were determined by serum assay. ; SECONDARY OUTCOME: Body mass index ; The body mass index (BMI) was calculated as weight (kg) / height square (m2). waist/hip ratio (WHR) ; Waist and hip circumferences were measured and waist/hip ratio (WHR) was calculated. INCLUSION CRITERIA: Polycystic ovary syndrome