The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory markers, vascular markers and bone development in overweight adolescent females with polycystic ovary syndrome (PCOS).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
4 mg daily for 6 months
1 tab (3mg/30mcg) daily for 6 months
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Peripheral Insulin Sensitivity at Baseline and 6 Months.
Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.
Time frame: Baseline and 6 months
Hepatic Insulin Sensitivity at Baseline and 6 Months.
Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.
Time frame: Baseline and 6 months
Glucose Tolerance Status at Baseline and 6 Months.
Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.
Time frame: Baseline and 6 months
Total Fat Mass at Baseline and 6 Months
DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass.
Time frame: Baseline and 6 months
Total Testosterone at Baseline and 6 Months
Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy.
Time frame: Baseline and 6 months
Percent Body Fat at Baseline and 6 Months
DXA scans were done to measure the percentage of body fat.
Time frame: Baseline and 6 months
Free Testosterone at Baseline and 6 Months
Free testosterone was measured by equilibrium dialysis.
Time frame: Baseline and 6 months
SHBG at Baseline and 6 Months
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SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay.
Time frame: Baseline and 6 months
DHEAS at Baseline and 6 Months
DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis.
Time frame: Baseline and 6 months
Delta Androstenedione at Baseline and 6 Months
Delta Androstenedione was measured by HPLC-tandem mass spectroscopy.
Time frame: Baseline and 6 months
Delta DHEA at Baseline and 6 Months
Delta DHEA was measured by HPLC-tandem mass spectroscopy.
Time frame: Baseline and 6 months
Delta 17-OHProg at Baseline and 6 Months
Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy.
Time frame: Baseline and 6 months
Delta 17-OHPreg at Baseline and 6 Months
Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy.
Time frame: Baseline and 6 months
Cholesterol at Baseline and 6 Months
Cholesterol was measured using the standards of the Centers for Disease Control and Prevention.
Time frame: Baseline and 6 months
HDL at Baseline and 6 Months
HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.
Time frame: Baseline and 6 months
LDL at Baseline and 6 Months
LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.
Time frame: Baseline and 6 months
Triglycerides at Baseline and 6 Months
Triglycerides were measured using the standards of the Centers for Disease Control and Prevention.
Time frame: Baseline and 6 months
Non-HDL Cholesterol at Baseline and 6 Months
Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention.
Time frame: Baseline and 6 months
Adiponectin at Baseline and 6 Months
Adiponectin was measured by radioimmunoassay.
Time frame: Baseline and 6 months
Leptin at Baseline and 6 Months
Leptin was measured by radioimmunoassay.
Time frame: Baseline and 6 months
Hs-CRP at Baseline and 6 Months
hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry.
Time frame: Baseline and 6 months
Morning Blood Pressure at Baseline and 6 Months
Morning blood pressure was measured with an automated sphygmomanometer.
Time frame: Baseline and 6 months
Night Blood Pressure at Baseline and 6 Months
Night blood pressure was measured with an automated sphygmomanometer.
Time frame: Baseline and 6 months