Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

• Sponsor: Silva Arslanian (Other)
• Overall Status: Completed
• CT.gov ID: NCT00640224
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 65
• Location: 1
• Arms: 4
• Duration (Months): 124
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: rosiglitazone; Drug: drospirenone/ethinyl estradiol	Phase 4

Detailed Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rosiglitazone Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone	Drug: rosiglitazone; 4 mg daily for 6 months; Other Names: Avandia
Active Comparator: Drospirenone/ethinyl estradiol Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol	Drug: drospirenone/ethinyl estradiol; 1 tab (3mg/30mcg) daily for 6 months; Other Names: Yasmin
No Intervention: Overweight/Obese without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes. *No participants were enrolled in this Arm.
No Intervention: Lean without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers. *No participants were enrolled in this Arm.

Outcome Measures

Primary Outcome Measures

1. Peripheral Insulin Sensitivity at Baseline and 6 Months. [Baseline and 6 months]

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

2. Hepatic Insulin Sensitivity at Baseline and 6 Months. [Baseline and 6 months]

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

3. Glucose Tolerance Status at Baseline and 6 Months. [Baseline and 6 months]

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

Secondary Outcome Measures

1. Total Fat Mass at Baseline and 6 Months [Baseline and 6 months]

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

2. Total Testosterone at Baseline and 6 Months [Baseline and 6 months]

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

3. Percent Body Fat at Baseline and 6 Months [Baseline and 6 months]

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

4. Free Testosterone at Baseline and 6 Months [Baseline and 6 months]

   Free testosterone was measured by equilibrium dialysis.

5. SHBG at Baseline and 6 Months [Baseline and 6 months]

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

6. DHEAS at Baseline and 6 Months [Baseline and 6 months]

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

7. Delta Androstenedione at Baseline and 6 Months [Baseline and 6 months]

   Delta Androstenedione was measured by HPLC-tandem mass spectroscopy.

8. Delta DHEA at Baseline and 6 Months [Baseline and 6 months]

   Delta DHEA was measured by HPLC-tandem mass spectroscopy.

9. Delta 17-OHProg at Baseline and 6 Months [Baseline and 6 months]

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

10. Delta 17-OHPreg at Baseline and 6 Months [Baseline and 6 months]

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

11. Cholesterol at Baseline and 6 Months [Baseline and 6 months]

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

12. HDL at Baseline and 6 Months [Baseline and 6 months]

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

13. LDL at Baseline and 6 Months [Baseline and 6 months]

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

14. Triglycerides at Baseline and 6 Months [Baseline and 6 months]

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

15. Non-HDL Cholesterol at Baseline and 6 Months [Baseline and 6 months]

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

16. Adiponectin at Baseline and 6 Months [Baseline and 6 months]

    Adiponectin was measured by radioimmunoassay.

17. Leptin at Baseline and 6 Months [Baseline and 6 months]

    Leptin was measured by radioimmunoassay.

18. Hs-CRP at Baseline and 6 Months [Baseline and 6 months]

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

19. Morning Blood Pressure at Baseline and 6 Months [Baseline and 6 months]

    Morning blood pressure was measured with an automated sphygmomanometer.

20. Night Blood Pressure at Baseline and 6 Months [Baseline and 6 months]

    Night blood pressure was measured with an automated sphygmomanometer.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 20 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15224

Sponsors and Collaborators

• Silva Arslanian
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Silva Arslanian, M.D., University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Silva Arslanian, Principal Investigator, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00640224
• Other Study ID Numbers: 0503013; 2K24HD001357
• First Posted: Mar 21, 2008
• Last Update Posted: Nov 17, 2017
• Last Verified: Oct 1, 2017

• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Syndrome; Rosiglitazone; Drospirenone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

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

Baseline Characteristics

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS	Total
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers	Total of all reporting groups
Overall Participants	17	20	0	0	37
Age (Count of Participants)
<=18 years	16 94.1%	18 90%	34 Infinity
Between 18 and 65 years	1 5.9%	2 10%	3 Infinity
>=65 years	0 0%	0 0%	0 NaN
Age (years) [Mean (Standard Deviation) ]
Age	15.7 (4.1)	16.2 (4.5)	16.0 (4.3)
Sex: Female, Male (Count of Participants)
Female	17 100%	20 100%	37 Infinity
Male	0 0%	0 0%	0 NaN
Region of Enrollment (participants) [Number]
United States	17 100%	20 100%	37 Infinity

Outcome Measures

1. Primary Outcome

Title	Peripheral Insulin Sensitivity at Baseline and 6 Months.
Description	Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Peripheral insulin sensitivity, Baseline	2.2 (0.2)	2.1 (0.2)
Peripheral insulin sensitivity, 6 months	3.2 (0.4)	2.0 (0.2)

2. Primary Outcome

Title	Hepatic Insulin Sensitivity at Baseline and 6 Months.
Description	Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Hepatic insulin sensitivity, Baseline	17.3 (1.8)	17.4 (2.2)
Hepatic insulin sensitivity, 6 months	24.1 (3.4)	16.8 (2.2)

3. Primary Outcome

Title	Glucose Tolerance Status at Baseline and 6 Months.
Description	Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Normal glucose tolerance, baseline	15 88.2%	12 60%
Impaired glucose tolerance, baseline	2 11.8%	8 40%
Normal glucose tolerance, 6 months	15 88.2%	13 65%
Impaired glucose tolerance, 6 months	2 11.8%	7 35%

4. Secondary Outcome

Title	Total Fat Mass at Baseline and 6 Months
Description	DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Fat mass, Baseline	44.5 (2.8)	48.0 (3.2)
Fat mass, 6 months	45.4 (3.4)	49.1 (3.4)

5. Secondary Outcome

Title	Total Testosterone at Baseline and 6 Months
Description	Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Total Testosterone, Baseline	45.7 (5.6)	34.5 (3.2)
Total Testosterone, 6 months	36.9 (3.7)	30.6 (3.1)

6. Secondary Outcome

Title	Percent Body Fat at Baseline and 6 Months
Description	DXA scans were done to measure the percentage of body fat.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Percent body fat, Baseline	46.2 (1.1)	47.3 (1.1)
Percent body fat, 6 months	46.6 (1.6)	48.2 (1.2)

7. Secondary Outcome

Title	Free Testosterone at Baseline and 6 Months
Description	Free testosterone was measured by equilibrium dialysis.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Free Testosterone, Baseline	10.7 (2.0)	7.5 (0.9)
Free Testosterone, 6 months	7.7 (1.6)	1.9 (0.3)

8. Secondary Outcome

Title	SHBG at Baseline and 6 Months
Description	SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
SHBG, Baseline	28.1 (4.6)	22.7 (2.2)
SHBG, 6 months	37.0 (6.6)	154.5 (24.0)

9. Secondary Outcome

Title	DHEAS at Baseline and 6 Months
Description	DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
DHEAS, Baseline	165.4 (17.0)	212.2 (25.4)
DHEAS, 6 months	160.9 (17.9)	197.5 (25.6)

10. Secondary Outcome

Title	Delta Androstenedione at Baseline and 6 Months
Description	Delta Androstenedione was measured by HPLC-tandem mass spectroscopy.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Delta Androstenedione, Baseline	79.2 (11.5)	82.6 (10.6)
Delta Androstenedione, 6 months	58.4 (9.5)	117.0 (18.2)

11. Secondary Outcome

Title	Delta DHEA at Baseline and 6 Months
Description	Delta DHEA was measured by HPLC-tandem mass spectroscopy.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Delta DHEA, Baseline	817.4 (119.5)	1001.6 (183.1)
Delta DHEA, 6 months	643.4 (102.4)	1092.1 (188.4)

12. Secondary Outcome

Title	Delta 17-OHProg at Baseline and 6 Months
Description	Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Delta 17-OHProg, Baseline	207.0 (37.4)	169.8 (37.3)
Delta 17-OHProg, 6 months	178.0 (49.1)	175.4 (46.5)

13. Secondary Outcome

Title	Delta 17-OHPreg at Baseline and 6 Months
Description	Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Delta 17-OHPreg, Baseline	912.8 (92.1)	1024.3 (114.5)
Delta 17-OHPreg, 6 months	914.7 (110.9)	1088.9 (161.0)

14. Secondary Outcome

Title	Cholesterol at Baseline and 6 Months
Description	Cholesterol was measured using the standards of the Centers for Disease Control and Prevention.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Cholesterol, Baseline	149.5 (8.1)	156.5 (6.9)
Cholesterol, 6 months	146.2 (7.9)	185.2 (9.1)

15. Secondary Outcome

Title	HDL at Baseline and 6 Months
Description	HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
HDL, Baseline	42.7 (3.0)	40.9 (1.9)
HDL, 6 months	46.1 (2.1)	55.0 (2.8)

16. Secondary Outcome

Title	LDL at Baseline and 6 Months
Description	LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
LDL, Baseline	85.4 (7.6)	85.9 (6.2)
LDL, 6 months	84.3 (7.5)	97.7 (7.4)

17. Secondary Outcome

Title	Triglycerides at Baseline and 6 Months
Description	Triglycerides were measured using the standards of the Centers for Disease Control and Prevention.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Triglycerides, Baseline	106.7 (8.1)	148.4 (14.8)
Triglycerides, 6 months	79.2 (6.3)	163.5 (14.9)

18. Secondary Outcome

Title	Non-HDL Cholesterol at Baseline and 6 Months
Description	Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Non-HDL cholesterol, Baseline	65.3 (2.0)	70.6 (3.5)
Non-HDL cholesterol, 6 months	62.3 (1.9)	87.6 (4.4)

19. Secondary Outcome

Title	Adiponectin at Baseline and 6 Months
Description	Adiponectin was measured by radioimmunoassay.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Adiponectin, Baseline	6.5 (0.7)	5.9 (0.4)
Adiponectin, 6 months	11.6 (1.2)	6.7 (0.5)

20. Secondary Outcome

Title	Leptin at Baseline and 6 Months
Description	Leptin was measured by radioimmunoassay.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Leptin, Baseline	43.8 (4.6)	40.6 (3.8)
Leptin, 6 months	42.7 (4.9)	46.8 (3.9)

21. Secondary Outcome

Title	Hs-CRP at Baseline and 6 Months
Description	hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
hs-CRP, Baseline	2.1 (0.6)	1.7 (0.5)
hs-CRP, 6 months	2.2 (1.0)	3.8 (0.7)

22. Secondary Outcome

Title	Morning Blood Pressure at Baseline and 6 Months
Description	Morning blood pressure was measured with an automated sphygmomanometer.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Morning Systolic BP, Baseline	108.2 (2.6)	108.5 (3.0)
Morning Diasytolic BP, Baseline	58.1 (2.0)	58.1 (1.7)
Morning Systolic BP, 6 months	107.5 (2.7)	112.2 (2.1)
Morning Diastolic BP, 6 months	58.7 (1.2)	59.5 (1.2)

23. Secondary Outcome

Title	Night Blood Pressure at Baseline and 6 Months
Description	Night blood pressure was measured with an automated sphygmomanometer.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rosiglitazone	Drospirenone/Ethinyl Estradiol	Overweight/Obese Without PCOS	Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months	Overweight adolescent females without PCOS to use as comparison of normal developmental changes.	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Measure Participants	17	20	0	0
Night Systolic BP, Baseline	117.5 (2.8)	112.9 (2.1)
Night Diastolic BP, Baseline	63.0 (1.5)	58.6 (1.6)
Night Systolic BP, 6 months	115.2 (2.5)	116.9 (1.9)
Night Diastolic BP, 6 months	61.7 (1.5)	62.6 (1.1)

Adverse Events

Arm/Group Title	Rosiglitazone		Drospirenone/Ethinyl Estradiol		Overweight/Obese Without PCOS		Lean Without PCOS
Arm/Group Description	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months		Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months		Overweight adolescent females without PCOS to use as comparison of normal developmental changes.		Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
All Cause Mortality
	Rosiglitazone		Drospirenone/Ethinyl Estradiol		Overweight/Obese Without PCOS		Lean Without PCOS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Rosiglitazone		Drospirenone/Ethinyl Estradiol		Overweight/Obese Without PCOS		Lean Without PCOS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/20 (0%)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Rosiglitazone		Drospirenone/Ethinyl Estradiol		Overweight/Obese Without PCOS		Lean Without PCOS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/20 (0%)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

The potential unblinding due to the rapid regulation of withdrawal bleeding which may have influenced the dropout rates;the short duration of treatment in contrast to clinical practice where treatment may be for several years.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.