Objective: To evaluate the combination of metformin and roflumilast in patients with polycystic ovary syndrome (PCOS). Methods:A total of 53 obese women with PCOS from June 2013 to June 2015 were investigated in this study. They were randomized to divide into control group (treatment with metformin, the initial 25 cases) and observed group (treatment with metformin and roflumilast, followed by 28 cases). Each group has been treated for three months. The weight, BMI, waist circumference, glucose, insulin, HOMA-IR, luteinizing hormone, follicle-stimulating hormone, androstenedione, and total and free testosterone were calculated before and after treatment. Results:After treatment with 3 months, the weight, BMI and waist circumference in observed group were significantly decreased (P<0.05), and there were significantly difference between two groups (P<0.001). Besides, the glucose and HOMA-IR were significantly difference between treatment groups (P<0.05). In addition, statistically significant within- and between-treatment differences were found in free testosterone and androstenedione (P<0.05). No difference was observed in serum total cholesterol (TC), triglycerides (TG), high-density lipoprotein-cholesterol (HDL-C) and low-density lipoprotein-cholesterol (LDL-C) before treatment, however there was significantly difference between two groups after treatment (P<0.05). Conclusions:Combined treatment with roflumilast and metformin could reduce body weight in obese women with PCOS, and it encourage further exploration of the use of this drug for PCOS [ABSTRACT FROM AUTHOR]