Trial Outcomes & Findings for Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study (NCT NCT00640224)

NCT ID: NCT00640224

Last Updated: 2017-11-17

Results Overview

Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 65 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2017-11-17

Participant Flow

Overweight/obese patients with PCOS were recruited from the Children's Hospital of Pittsburgh (CHP) PCOS center and the community through advertisements and flyers posted in the medical campus and in pediatricians' offices.

9 did not meet diagnostic criteria, 3 were on psychiatric meds,1 was diagnosed with diabetes,1 had venous access issues, and 5 did not complete baseline evaluations. No participants were enrolled in the "Overweight/Obese without PCOS" or "Lean without PCOS" Arms/Groups.

Participant milestones

Measure	Rosiglitazone Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Overall Study STARTED	23	23	0	0
Overall Study COMPLETED	17	20	0	0
Overall Study NOT COMPLETED	6	3	0	0

Reasons for withdrawal

Measure	Rosiglitazone Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Overall Study Lost to Follow-up	5	2	0	0
Overall Study Withdrawal by Subject	1	0	0	0
Overall Study Headaches	0	1	0	0

Baseline Characteristics

Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

Baseline characteristics by cohort

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers	Total n=37 Participants Total of all reporting groups
Age, Categorical Age · <=18 years	16 Participants n=5 Participants	18 Participants n=7 Participants	—	—	34 Participants n=21 Participants
Age, Categorical Age · Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	—	—	3 Participants n=21 Participants
Age, Categorical Age · >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Age, Continuous Age	15.7 years STANDARD_DEVIATION 4.1 • n=5 Participants	16.2 years STANDARD_DEVIATION 4.5 • n=7 Participants	—	—	16.0 years STANDARD_DEVIATION 4.3 • n=21 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	20 Participants n=7 Participants	—	—	37 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Region of Enrollment United States	17 participants n=5 Participants	20 participants n=7 Participants	—	—	37 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Peripheral Insulin Sensitivity at Baseline and 6 Months. Peripheral insulin sensitivity, Baseline	2.2 mg/kg/min per uU/mL Standard Error 0.2	2.1 mg/kg/min per uU/mL Standard Error 0.2	—	—
Peripheral Insulin Sensitivity at Baseline and 6 Months. Peripheral insulin sensitivity, 6 months	3.2 mg/kg/min per uU/mL Standard Error 0.4	2.0 mg/kg/min per uU/mL Standard Error 0.2	—	—

PRIMARY outcome

Timeframe: Baseline and 6 months

Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Hepatic Insulin Sensitivity at Baseline and 6 Months. Hepatic insulin sensitivity, Baseline	17.3 (mg/kg/min x uU/mL)-1 Standard Error 1.8	17.4 (mg/kg/min x uU/mL)-1 Standard Error 2.2	—	—
Hepatic Insulin Sensitivity at Baseline and 6 Months. Hepatic insulin sensitivity, 6 months	24.1 (mg/kg/min x uU/mL)-1 Standard Error 3.4	16.8 (mg/kg/min x uU/mL)-1 Standard Error 2.2	—	—

PRIMARY outcome

Timeframe: Baseline and 6 months

Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Glucose Tolerance Status at Baseline and 6 Months. Normal glucose tolerance, baseline	15 Participants	12 Participants	—	—
Glucose Tolerance Status at Baseline and 6 Months. Impaired glucose tolerance, baseline	2 Participants	8 Participants	—	—
Glucose Tolerance Status at Baseline and 6 Months. Normal glucose tolerance, 6 months	15 Participants	13 Participants	—	—
Glucose Tolerance Status at Baseline and 6 Months. Impaired glucose tolerance, 6 months	2 Participants	7 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Total Fat Mass at Baseline and 6 Months Fat mass, Baseline	44.5 Kg Standard Error 2.8	48.0 Kg Standard Error 3.2	—	—
Total Fat Mass at Baseline and 6 Months Fat mass, 6 months	45.4 Kg Standard Error 3.4	49.1 Kg Standard Error 3.4	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Total Testosterone at Baseline and 6 Months Total Testosterone, Baseline	45.7 ng/dL Standard Error 5.6	34.5 ng/dL Standard Error 3.2	—	—
Total Testosterone at Baseline and 6 Months Total Testosterone, 6 months	36.9 ng/dL Standard Error 3.7	30.6 ng/dL Standard Error 3.1	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

DXA scans were done to measure the percentage of body fat.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Percent Body Fat at Baseline and 6 Months Percent body fat, Baseline	46.2 percentage of body fat Standard Error 1.1	47.3 percentage of body fat Standard Error 1.1	—	—
Percent Body Fat at Baseline and 6 Months Percent body fat, 6 months	46.6 percentage of body fat Standard Error 1.6	48.2 percentage of body fat Standard Error 1.2	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Free testosterone was measured by equilibrium dialysis.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Free Testosterone at Baseline and 6 Months Free Testosterone, Baseline	10.7 pg/mL Standard Error 2.0	7.5 pg/mL Standard Error 0.9	—	—
Free Testosterone at Baseline and 6 Months Free Testosterone, 6 months	7.7 pg/mL Standard Error 1.6	1.9 pg/mL Standard Error 0.3	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
SHBG at Baseline and 6 Months SHBG, 6 months	37.0 nmol/L Standard Error 6.6	154.5 nmol/L Standard Error 24.0	—	—
SHBG at Baseline and 6 Months SHBG, Baseline	28.1 nmol/L Standard Error 4.6	22.7 nmol/L Standard Error 2.2	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
DHEAS at Baseline and 6 Months DHEAS, Baseline	165.4 ug/dL Standard Error 17.0	212.2 ug/dL Standard Error 25.4	—	—
DHEAS at Baseline and 6 Months DHEAS, 6 months	160.9 ug/dL Standard Error 17.9	197.5 ug/dL Standard Error 25.6	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Delta Androstenedione was measured by HPLC-tandem mass spectroscopy.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Delta Androstenedione at Baseline and 6 Months Delta Androstenedione, Baseline	79.2 ng/dL Standard Error 11.5	82.6 ng/dL Standard Error 10.6	—	—
Delta Androstenedione at Baseline and 6 Months Delta Androstenedione, 6 months	58.4 ng/dL Standard Error 9.5	117.0 ng/dL Standard Error 18.2	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Delta DHEA was measured by HPLC-tandem mass spectroscopy.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Delta DHEA at Baseline and 6 Months Delta DHEA, Baseline	817.4 ug/dL Standard Error 119.5	1001.6 ug/dL Standard Error 183.1	—	—
Delta DHEA at Baseline and 6 Months Delta DHEA, 6 months	643.4 ug/dL Standard Error 102.4	1092.1 ug/dL Standard Error 188.4	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Delta 17-OHProg at Baseline and 6 Months Delta 17-OHProg, Baseline	207.0 ng/dL Standard Error 37.4	169.8 ng/dL Standard Error 37.3	—	—
Delta 17-OHProg at Baseline and 6 Months Delta 17-OHProg, 6 months	178.0 ng/dL Standard Error 49.1	175.4 ng/dL Standard Error 46.5	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Delta 17-OHPreg at Baseline and 6 Months Delta 17-OHPreg, Baseline	912.8 ng/dL Standard Error 92.1	1024.3 ng/dL Standard Error 114.5	—	—
Delta 17-OHPreg at Baseline and 6 Months Delta 17-OHPreg, 6 months	914.7 ng/dL Standard Error 110.9	1088.9 ng/dL Standard Error 161.0	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Cholesterol was measured using the standards of the Centers for Disease Control and Prevention.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Cholesterol at Baseline and 6 Months Cholesterol, Baseline	149.5 mg/dL Standard Error 8.1	156.5 mg/dL Standard Error 6.9	—	—
Cholesterol at Baseline and 6 Months Cholesterol, 6 months	146.2 mg/dL Standard Error 7.9	185.2 mg/dL Standard Error 9.1	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
HDL at Baseline and 6 Months HDL, Baseline	42.7 mg/dL Standard Error 3.0	40.9 mg/dL Standard Error 1.9	—	—
HDL at Baseline and 6 Months HDL, 6 months	46.1 mg/dL Standard Error 2.1	55.0 mg/dL Standard Error 2.8	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
LDL at Baseline and 6 Months LDL, Baseline	85.4 mg/dL Standard Error 7.6	85.9 mg/dL Standard Error 6.2	—	—
LDL at Baseline and 6 Months LDL, 6 months	84.3 mg/dL Standard Error 7.5	97.7 mg/dL Standard Error 7.4	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Triglycerides were measured using the standards of the Centers for Disease Control and Prevention.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Triglycerides at Baseline and 6 Months Triglycerides, Baseline	106.7 mg/dL Standard Error 8.1	148.4 mg/dL Standard Error 14.8	—	—
Triglycerides at Baseline and 6 Months Triglycerides, 6 months	79.2 mg/dL Standard Error 6.3	163.5 mg/dL Standard Error 14.9	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Non-HDL Cholesterol at Baseline and 6 Months Non-HDL cholesterol, Baseline	65.3 mg/dL Standard Error 2.0	70.6 mg/dL Standard Error 3.5	—	—
Non-HDL Cholesterol at Baseline and 6 Months Non-HDL cholesterol, 6 months	62.3 mg/dL Standard Error 1.9	87.6 mg/dL Standard Error 4.4	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Adiponectin was measured by radioimmunoassay.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Adiponectin at Baseline and 6 Months Adiponectin, Baseline	6.5 ug/mL Standard Error 0.7	5.9 ug/mL Standard Error 0.4	—	—
Adiponectin at Baseline and 6 Months Adiponectin, 6 months	11.6 ug/mL Standard Error 1.2	6.7 ug/mL Standard Error 0.5	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Leptin was measured by radioimmunoassay.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Leptin at Baseline and 6 Months Leptin, Baseline	43.8 ng/mL Standard Error 4.6	40.6 ng/mL Standard Error 3.8	—	—
Leptin at Baseline and 6 Months Leptin, 6 months	42.7 ng/mL Standard Error 4.9	46.8 ng/mL Standard Error 3.9	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Hs-CRP at Baseline and 6 Months hs-CRP, Baseline	2.1 mg/L Standard Error 0.6	1.7 mg/L Standard Error 0.5	—	—
Hs-CRP at Baseline and 6 Months hs-CRP, 6 months	2.2 mg/L Standard Error 1.0	3.8 mg/L Standard Error 0.7	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Morning blood pressure was measured with an automated sphygmomanometer.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Morning Blood Pressure at Baseline and 6 Months Morning Systolic BP, Baseline	108.2 mm Hg Standard Error 2.6	108.5 mm Hg Standard Error 3.0	—	—
Morning Blood Pressure at Baseline and 6 Months Morning Diasytolic BP, Baseline	58.1 mm Hg Standard Error 2.0	58.1 mm Hg Standard Error 1.7	—	—
Morning Blood Pressure at Baseline and 6 Months Morning Systolic BP, 6 months	107.5 mm Hg Standard Error 2.7	112.2 mm Hg Standard Error 2.1	—	—
Morning Blood Pressure at Baseline and 6 Months Morning Diastolic BP, 6 months	58.7 mm Hg Standard Error 1.2	59.5 mm Hg Standard Error 1.2	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Night blood pressure was measured with an automated sphygmomanometer.

Outcome measures

Measure	Rosiglitazone n=17 Participants Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Drospirenone/Ethinyl Estradiol n=20 Participants Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Night Blood Pressure at Baseline and 6 Months Night Systolic BP, Baseline	117.5 mm Hg Standard Error 2.8	112.9 mm Hg Standard Error 2.1	—	—
Night Blood Pressure at Baseline and 6 Months Night Diastolic BP, Baseline	63.0 mm Hg Standard Error 1.5	58.6 mm Hg Standard Error 1.6	—	—
Night Blood Pressure at Baseline and 6 Months Night Systolic BP, 6 months	115.2 mm Hg Standard Error 2.5	116.9 mm Hg Standard Error 1.9	—	—
Night Blood Pressure at Baseline and 6 Months Night Diastolic BP, 6 months	61.7 mm Hg Standard Error 1.5	62.6 mm Hg Standard Error 1.1	—	—

Adverse Events

Rosiglitazone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Drospirenone/Ethinyl Estradiol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Overweight/Obese Without PCOS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lean Without PCOS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Silva Arslanian

Children's Hospital of Pittsburgh of UPMC

Phone: 412-692-6935

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place