MLE4901- Research Study for women with PCOS (Polycystic Ovary Syndrome)

This study is researching the efficacy and safety of the investigational drug MLE4901 and how it works in treating PCOS (Polycystic ovary syndrome). An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). The study drug is not approved for doctors to treat patients with PCOS. Women who are diagnosed with PCOS exhibit excessive amounts or effects of androgenic hormones, resulting in acne, hirsutism and insulin resistance, often associated with obesity, type 2 diabetes mellitus and high cholesterol levels. The symptoms and severity of the syndrome vary greatly among affected women. This treatment could potentially control the symptoms of PCOS and restore regular menses and ovulation. Your expected participation in this study will last about 11 months, with 12 site visits. During this time, you will receive physical and gynecological exams, an ECG and a Transvaginal Ultrasound. If you qualify for the study, you will have a 75% (3 in 4) chance of receiving MLE4901 (40 mg, 60 mg, or 80 mg twice daily), and a 1 in 4 chance of receiving placebo (inactive tablets, sometimes called "sugar pills") twice daily. You will also be asked to complete an electronic diary daily and to collect urine samples. You will be compensated for your time and travel for participating in this study.