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Trial record 13 of 30 for:    nichd Polycystic Ovary Syndrome (PCOS)

Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00640224
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Silva Arslanian, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Polycystic Ovary Syndrome
Interventions Drug: rosiglitazone
Drug: drospirenone/ethinyl estradiol
Enrollment 65
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 Details 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
Hide 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
Reason Not Completed
Lost to Follow-up             5             2             0             0
Withdrawal by Subject             1             0             0             0
Headaches             0             1             0             0
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS Total
Hide 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 Number of Baseline Participants 17 20 0 0 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 17 participants 20 participants 0 participants 0 participants 37 participants
<=18 years
16
  94.1%
18
  90.0%
34
  91.9%
Between 18 and 65 years
1
   5.9%
2
  10.0%
3
   8.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 17 participants 20 participants 0 participants 0 participants 37 participants
15.7  (4.1) 16.2  (4.5) 16.0  (4.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 20 participants 0 participants 0 participants 37 participants
Female
17
 100.0%
20
 100.0%
37
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 20 participants 0 participants 0 participants 37 participants
17 20 37
1.Primary Outcome
Title Peripheral Insulin Sensitivity at Baseline and 6 Months.
Hide Description Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: mg/kg/min per uU/mL
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.
Hide Description Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: (mg/kg/min x uU/mL)-1
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.
Hide Description Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Normal glucose tolerance, baseline
15
  88.2%
12
  60.0%
Impaired glucose tolerance, baseline
2
  11.8%
8
  40.0%
Normal glucose tolerance, 6 months
15
  88.2%
13
  65.0%
Impaired glucose tolerance, 6 months
2
  11.8%
7
  35.0%
4.Secondary Outcome
Title Total Fat Mass at Baseline and 6 Months
Hide Description DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: Kg
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
Hide Description Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: ng/dL
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
Hide Description DXA scans were done to measure the percentage of body fat.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: percentage of body fat
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
Hide Description Free testosterone was measured by equilibrium dialysis.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: pg/mL
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
Hide Description SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: nmol/L
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
Hide Description DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: ug/dL
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
Hide Description Delta Androstenedione was measured by HPLC-tandem mass spectroscopy.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: ng/dL
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
Hide Description Delta DHEA was measured by HPLC-tandem mass spectroscopy.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: ug/dL
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
Hide Description Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: ng/dL
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
Hide Description Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: ng/dL
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
Hide Description Cholesterol was measured using the standards of the Centers for Disease Control and Prevention.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: mg/dL
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
Hide Description HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: mg/dL
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
Hide Description LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: mg/dL
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
Hide Description Triglycerides were measured using the standards of the Centers for Disease Control and Prevention.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: mg/dL
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
Hide Description Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: mg/dL
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
Hide Description Adiponectin was measured by radioimmunoassay.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: ug/mL
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
Hide Description Leptin was measured by radioimmunoassay.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: ng/mL
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
Hide Description hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: mg/L
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
Hide Description Morning blood pressure was measured with an automated sphygmomanometer.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: mm Hg
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
Hide Description Night blood pressure was measured with an automated sphygmomanometer.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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
Overall Number of Participants Analyzed 17 20 0 0
Mean (Standard Error)
Unit of Measure: mm Hg
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/20 (0.00%)   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rosiglitazone Drospirenone/Ethinyl Estradiol Overweight/Obese Without PCOS Lean Without PCOS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/20 (0.00%)   0/0   0/0 
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.
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.
Results Point of Contact
Name/Title: Dr. Silva Arslanian
Organization: Children's Hospital of Pittsburgh of UPMC
Phone: 412-692-6935
Responsible Party: Silva Arslanian, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00640224     History of Changes
Other Study ID Numbers: 0503013
2K24HD001357 ( U.S. NIH Grant/Contract )
First Submitted: March 18, 2008
First Posted: March 21, 2008
Results First Submitted: July 27, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017