Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

The purpose of this study is to:

1) to compare effects of treatment with drospirenone/ethinyl estradiol (Yasmin)versus
rosiglitazone (Avandia) on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal
hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover.

OCPs are the first-line therapy for PCOS, however, they do not address the insulin resistance
or the inflammation. Insulin sensitizers have been used successfully to treat PCOS but
thiazolidinediones such as rosiglitazone have not been used in adolescents. Therefore we will
investigate the effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone
in overweight adolescents with PCOS. We will obtain comprehensive evaluations before and 6
months after randomization, to the respective treatment arms to determine the differences
between the 2 treatment modalities.

Inclusion Criteria:

- Age 10 - 20 years

- Pubertal level of Tanner stage III-V and menarchal

- BMI percentile for age and sex greater than or equal to 85%ile

Exclusion Criteria:

- Oral medications for PCOS, or that have impact on bone (i.e. anti-epileptics)

- Presence of other diseases, systemic or psychiatric, or chronic medications which
could interfere with endocrine function

- Established diagnosis of diabetes

- Prior bone surgery, prior osteoporotic fracture, or fracture in the past 12 months

- Prior thromboembolic event, such as a deep venous thrombosis or pulmonary embolism
(PCOS subjects only)

- Vitamin D deficiency (<10ng/mL)

- Hyperkalemia (K>5.0 meq/L)

- Positive pregnancy test (serum)