Role of the combination spironolactone– norgestimate–estrogen in hirsute women with polycystic ovary syndrome

OBJECTIVE: To compare the combination spironolactone– norgestimate–ethinyl estradiol in hirsutism with other protocols including the same dose of estrogen. STUDY DESIGN: In this open prospective study, 167 women with hirsutism due to polycystic ovary syndrome (PCOS) were randomly assigned to the following treatment protocols: Group A (n=72): spironolactone 100 mg–norgestimate 250 mcg– ethinyl estradiol 35 μg; Group B (n=70): cyproterone acetate 12 mg–ethinyl estradiol 35 μg; Group C (n=25): norgestimate 250 μg–ethinyl estradiol 35 μg. RESULTS: The decrease in the hirsutism score was higher in group A than in the other groups (p<0.001) and comparable in groups B and C. The decrease in acne score, androgen and estradiol levels, and ovary volume was similar in groups A and B. C-reactive protein increase was similar in all groups, but the augmentation of fibrinogen (p=0.04), triglycerides (p<0.01), monocyte count (p=0.04), platelet number (p<0.001) and mean volume (p=0.01) was more pronounced in group B than in group A. Low-density lipoprotein/highdensity lipoprotein cholesterol ratio decreased in groups A and C. CONCLUSION: Spironolactone–norgestimate–ethinyl estradiol is an effective and well-tolerated combination for the treatment of hirsutism in PCOS, with a favorable influence on lipids and indices of low-grade inflammation.