Study aims to determine if Saxenda® , a weight loss drug, is effective in reducing body weight and excessive male hormones in obese women with PCOS
Woman’s Hospital is launching a clinical trial to determine if a weight loss drug is effective in reducing weight as well as excessive male hormones in obese women with Polycystic Ovary Syndrome (PCOS).
PCOS is a condition characterized by disordered reproductive and metabolic function, including excessive levels of androgens, or male sex hormones such as testosterone; chronic anovulation, or when ovulation does not occur; insulin resistance; obesity; and dyslipidemia, or having blood lipid levels that are too high or too low. PCOS is the most common reproductive endocrine disorder in women, affecting 8% to 18% of the female population, depending on the diagnostic criteria used.
Obesity plays a central role in the development of PCOS, and exacerbates reproductive and metabolic dysfunction. Women with PCOS are more likely to be overweight or obese; obesity is present in up to 70% of cases. Evidence suggests that medical treatment using drugs that manage obesity may modify the physiological and behavioral processes that contribute to weight gain and impede weight loss.
Saxenda® (Liraglutide 3 mg) is a prescription injectable medicine that is FDA-approved for weight loss. Research has shown that higher doses of drugs like Saxenda® for at least 20 weeks leads to weight loss in obese patients with or without type 2 diabetes. These weight loss effects previously demonstrated offer a unique opportunity to expand the medical options available to obese PCOS patients.
A new study aims to determine how Saxenda® treatment for 32 weeks affects:
- Body weight reduction
- Free androgen levels
- Menstrual cyclicity
- Glucose regulation
- Insulin sensitivity and secretion
- Body composition
- Cardiometabolic markers (lipids, blood pressure)
To participate in the study, patients must meet the following criteria:
- Age 18-45
- Body Mass Index (BMI) of greater than 30
- Diagnosed with PCOS, particularly hyperandrogenism and irregular menstrual cyclicity
- Willing to use effective non-hormonal contraception consistently
Medication, office visits, lab tests and compensation are provided. For more information on the SAXA PCOS trial, please contact Dr. Karen Elkind-Hirsch or Donna Shaler in Woman’s Research Department at 225-231-5275.