This study is researching the effects of the investigational drug, LIK066 and whether it can be developed for the treatment of polycystic ovary syndrome (PCOS) in overweight and obese women. 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 (like acne, hirsuitism and alopecia) and often associated with obesity, type 2 diabetes mellitus and high cholesterol levels. The symptoms and severity of the syndrome vary greatly among affected women.
Your expected participation in this study will last about 9 weeks, with approximately 6 site visits. During this time, you will receive physical, laboratory assessments and an ECG. If you qualify for the study, you will have a 50% (1 in 2) chance of receiving LIK066 (50 mg three times daily before breakfast, lunch and dinner), and a 1 in 2 chance of receiving placebo (inactive tablets, sometimes called "sugar pills") three times daily. You will be compensated for your time and travel for participating in this study.
Participation in this study involves:
• frequent site visits
• study related medical exams
• blood tests
• investigational medication (including possibility of placebo)
• Overweight women ages 18-45
• ≤8 menstrual cycles per year off of any hormone therapy not seeking pregnancy
• diagnosis of PCOS or suspected PCOS
Qualified participants will receive:
• Medical exams
• Compensation for time and travel ($50-$250 per completed visit)
If you are interested in seeing if you qualify for this study, click here or call 215.662.7727
Anuja Dokras, MD, PhD