Introducing the PILL Study(Polycystic Ovary Syndrome Impacted by Low-dose Oral Contraceptive with FoLate)
Woman’s Investigates New Folate-Supplemented Oral Contraceptive in Reducing Elevated Male Hormones in Women with Polycystic Ovary Syndrome
Woman’s Hospital announces the PILL study to determine the effectiveness of a new, low-dose oral contraceptive containing folate (a B vitamin) in reducing excessive male hormone levels in women with Polycystic Ovary Syndrome (PCOS). PCOS, one of the most common endocrine disorders in reproductive age women, is characterized by elevated levels of male hormones (androgens) which often presents with symptoms such as facial and body hair, weight gain, and infertility.
“When a woman is diagnosed with PCOS. there is an imbalance in the hormones and too much androgen is produced,” explains study principal investigator Dr. Karen Elkind-Hirsch, Woman’s Hospital Scientific Director of Research. “It is not completely understood why or how the changes in the levels occur, but it involves both a genetic and environment component.”
“For the past decade, oral contraceptives have been the first line of therapy to treat PCOS, however there is very limited research which systematically evaluated if weight plays a role in this medication’s effectiveness,” explains Dr. Elkind-Hirsch. “One of the clinical signs of PCOS is the tendency to gain weight easily and women with this disorder often have a body mass index (BMI) greater than 30 and are obese. By monitoring obese and non-obese women with PCOS, this study will determine the role weight plays in the clinical effectiveness of oral contraceptive treatment in PCOS women.”
The PILL Study is an open label, parallel-group study which means all women will be given the same oral contraceptives. The study will include 75 healthy, premenopausal women, ages 18 to 35 years with diagnosed PCOS who desire contraceptive therapy. All women must meet study requirements and will undergo clinical, metabolic, and lab evaluations before, during, and after the 6 month period to determine the pills’ effectiveness. For more information, patients may contact the Woman’s Hospital Research at 225-231-5275.
The effectiveness of the oral contraceptives treatment in all PCOS patient groups will be determined by the following:
- Laboratory evaluations of male hormones
- Cardiometabolic markers
- Carbohydrate metabolism
- Menstrual cycle regulation