Polycystic Ovary Syndrome
Conditions
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).
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.
Interventions
DRUGrosiglitazone
4 mg daily for 6 months
1 tab (3mg/30mcg) daily for 6 months
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Silva Arslanian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 20 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Insulin Sensitivity at Baseline and 6 Months. | Baseline and 6 months | Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp. |
| Hepatic Insulin Sensitivity at Baseline and 6 Months. | Baseline and 6 months | Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Free Testosterone at Baseline and 6 Months | Baseline and 6 months | Free testosterone was measured by equilibrium dialysis. |
| SHBG at Baseline and 6 Months | Baseline and 6 months | SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay. |
| DHEAS at Baseline and 6 Months | Baseline and 6 months | DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis. |
| Delta Androstenedione at Baseline and 6 Months | Baseline and 6 months | Delta Androstenedione was measured by HPLC-tandem mass spectroscopy. |
| Delta DHEA at Baseline and 6 Months | Baseline and 6 months | Delta DHEA was measured by HPLC-tandem mass spectroscopy. |
| Delta 17-OHProg at Baseline and 6 Months | Baseline and 6 months | Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy. |
| Delta 17-OHPreg at Baseline and 6 Months | Baseline and 6 months | Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy. |
| Cholesterol at Baseline and 6 Months | Baseline and 6 months | Cholesterol was measured using the standards of the Centers for Disease Control and Prevention. |
| 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. |
| 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. |
| Triglycerides at Baseline and 6 Months | Baseline and 6 months | Triglycerides were measured using the standards of the Centers for Disease Control and Prevention. |
| 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. |
| Adiponectin at Baseline and 6 Months | Baseline and 6 months | Adiponectin was measured by radioimmunoassay. |
| Leptin at Baseline and 6 Months | Baseline and 6 months | Leptin was measured by radioimmunoassay. |
| Hs-CRP at Baseline and 6 Months | Baseline and 6 months | hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry. |
| Morning Blood Pressure at Baseline and 6 Months | Baseline and 6 months | Morning blood pressure was measured with an automated sphygmomanometer. |
| Night Blood Pressure at Baseline and 6 Months | Baseline and 6 months | Night blood pressure was measured with an automated sphygmomanometer. |
| 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. |
| Total Testosterone at Baseline and 6 Months | Baseline and 6 months | Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy. |
| Percent Body Fat at Baseline and 6 Months | Baseline and 6 months | DXA scans were done to measure the percentage of body fat. |
Countries
United States
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 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.
Participants by arm
| Arm | Count |
|---|---|
| Rosiglitazone Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone
rosiglitazone: 4 mg daily for 6 months | 17 |
| 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 | 20 |
| Overweight/Obese Without PCOS Overweight adolescent females without PCOS to use as comparison of normal developmental changes. | 0 |
| Lean Without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers | 0 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Headaches | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 5 | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Drospirenone/Ethinyl Estradiol | Rosiglitazone | Total |
|---|---|---|---|
| Age, Categorical Age <=18 years | 18 Participants | 16 Participants | 34 Participants |
| Age, Categorical Age >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Age Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Continuous Age | 16.2 years STANDARD_DEVIATION 4.5 | 15.7 years STANDARD_DEVIATION 4.1 | 16.0 years STANDARD_DEVIATION 4.3 |
| Region of Enrollment United States | 20 participants | 17 participants | 37 participants |
| Sex: Female, Male Female | 20 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 20 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 17 | 0 / 20 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Glucose Tolerance Status at Baseline and 6 Months.
Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rosiglitazone | Glucose Tolerance Status at Baseline and 6 Months. | Normal glucose tolerance, baseline | 15 Participants |
| Rosiglitazone | Glucose Tolerance Status at Baseline and 6 Months. | Impaired glucose tolerance, baseline | 2 Participants |
| Rosiglitazone | Glucose Tolerance Status at Baseline and 6 Months. | Normal glucose tolerance, 6 months | 15 Participants |
| Rosiglitazone | Glucose Tolerance Status at Baseline and 6 Months. | Impaired glucose tolerance, 6 months | 2 Participants |
| Drospirenone/Ethinyl Estradiol | Glucose Tolerance Status at Baseline and 6 Months. | Impaired glucose tolerance, 6 months | 7 Participants |
| Drospirenone/Ethinyl Estradiol | Glucose Tolerance Status at Baseline and 6 Months. | Normal glucose tolerance, baseline | 12 Participants |
| Drospirenone/Ethinyl Estradiol | Glucose Tolerance Status at Baseline and 6 Months. | Normal glucose tolerance, 6 months | 13 Participants |
| Drospirenone/Ethinyl Estradiol | Glucose Tolerance Status at Baseline and 6 Months. | Impaired glucose tolerance, baseline | 8 Participants |
Primary
Hepatic Insulin Sensitivity at Baseline and 6 Months.
Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | 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 |
| Rosiglitazone | 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 |
| Drospirenone/Ethinyl Estradiol | Hepatic Insulin Sensitivity at Baseline and 6 Months. | Hepatic insulin sensitivity, Baseline | 17.4 (mg/kg/min x uU/mL)-1 | Standard Error 2.2 |
| Drospirenone/Ethinyl Estradiol | Hepatic Insulin Sensitivity at Baseline and 6 Months. | Hepatic insulin sensitivity, 6 months | 16.8 (mg/kg/min x uU/mL)-1 | Standard Error 2.2 |
Primary
Peripheral Insulin Sensitivity at Baseline and 6 Months.
Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Peripheral Insulin Sensitivity at Baseline and 6 Months. | Peripheral insulin sensitivity, Baseline | 2.2 mg/kg/min per uU/mL | Standard Error 0.2 |
| Rosiglitazone | 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 |
| Drospirenone/Ethinyl Estradiol | Peripheral Insulin Sensitivity at Baseline and 6 Months. | Peripheral insulin sensitivity, Baseline | 2.1 mg/kg/min per uU/mL | Standard Error 0.2 |
| Drospirenone/Ethinyl Estradiol | Peripheral Insulin Sensitivity at Baseline and 6 Months. | Peripheral insulin sensitivity, 6 months | 2.0 mg/kg/min per uU/mL | Standard Error 0.2 |
Secondary
Adiponectin at Baseline and 6 Months
Adiponectin was measured by radioimmunoassay.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Adiponectin at Baseline and 6 Months | Adiponectin, Baseline | 6.5 ug/mL | Standard Error 0.7 |
| Rosiglitazone | Adiponectin at Baseline and 6 Months | Adiponectin, 6 months | 11.6 ug/mL | Standard Error 1.2 |
| Drospirenone/Ethinyl Estradiol | Adiponectin at Baseline and 6 Months | Adiponectin, Baseline | 5.9 ug/mL | Standard Error 0.4 |
| Drospirenone/Ethinyl Estradiol | Adiponectin at Baseline and 6 Months | Adiponectin, 6 months | 6.7 ug/mL | Standard Error 0.5 |
Secondary
Cholesterol at Baseline and 6 Months
Cholesterol was measured using the standards of the Centers for Disease Control and Prevention.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Cholesterol at Baseline and 6 Months | Cholesterol, Baseline | 149.5 mg/dL | Standard Error 8.1 |
| Rosiglitazone | Cholesterol at Baseline and 6 Months | Cholesterol, 6 months | 146.2 mg/dL | Standard Error 7.9 |
| Drospirenone/Ethinyl Estradiol | Cholesterol at Baseline and 6 Months | Cholesterol, Baseline | 156.5 mg/dL | Standard Error 6.9 |
| Drospirenone/Ethinyl Estradiol | Cholesterol at Baseline and 6 Months | Cholesterol, 6 months | 185.2 mg/dL | Standard Error 9.1 |
Secondary
Delta 17-OHPreg at Baseline and 6 Months
Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Delta 17-OHPreg at Baseline and 6 Months | Delta 17-OHPreg, Baseline | 912.8 ng/dL | Standard Error 92.1 |
| Rosiglitazone | Delta 17-OHPreg at Baseline and 6 Months | Delta 17-OHPreg, 6 months | 914.7 ng/dL | Standard Error 110.9 |
| Drospirenone/Ethinyl Estradiol | Delta 17-OHPreg at Baseline and 6 Months | Delta 17-OHPreg, Baseline | 1024.3 ng/dL | Standard Error 114.5 |
| Drospirenone/Ethinyl Estradiol | Delta 17-OHPreg at Baseline and 6 Months | Delta 17-OHPreg, 6 months | 1088.9 ng/dL | Standard Error 161 |
Secondary
Delta 17-OHProg at Baseline and 6 Months
Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Delta 17-OHProg at Baseline and 6 Months | Delta 17-OHProg, Baseline | 207.0 ng/dL | Standard Error 37.4 |
| Rosiglitazone | Delta 17-OHProg at Baseline and 6 Months | Delta 17-OHProg, 6 months | 178.0 ng/dL | Standard Error 49.1 |
| Drospirenone/Ethinyl Estradiol | Delta 17-OHProg at Baseline and 6 Months | Delta 17-OHProg, Baseline | 169.8 ng/dL | Standard Error 37.3 |
| Drospirenone/Ethinyl Estradiol | Delta 17-OHProg at Baseline and 6 Months | Delta 17-OHProg, 6 months | 175.4 ng/dL | Standard Error 46.5 |
Secondary
Delta Androstenedione at Baseline and 6 Months
Delta Androstenedione was measured by HPLC-tandem mass spectroscopy.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Delta Androstenedione at Baseline and 6 Months | Delta Androstenedione, Baseline | 79.2 ng/dL | Standard Error 11.5 |
| Rosiglitazone | Delta Androstenedione at Baseline and 6 Months | Delta Androstenedione, 6 months | 58.4 ng/dL | Standard Error 9.5 |
| Drospirenone/Ethinyl Estradiol | Delta Androstenedione at Baseline and 6 Months | Delta Androstenedione, Baseline | 82.6 ng/dL | Standard Error 10.6 |
| Drospirenone/Ethinyl Estradiol | Delta Androstenedione at Baseline and 6 Months | Delta Androstenedione, 6 months | 117.0 ng/dL | Standard Error 18.2 |
Secondary
Delta DHEA at Baseline and 6 Months
Delta DHEA was measured by HPLC-tandem mass spectroscopy.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Delta DHEA at Baseline and 6 Months | Delta DHEA, Baseline | 817.4 ug/dL | Standard Error 119.5 |
| Rosiglitazone | Delta DHEA at Baseline and 6 Months | Delta DHEA, 6 months | 643.4 ug/dL | Standard Error 102.4 |
| Drospirenone/Ethinyl Estradiol | Delta DHEA at Baseline and 6 Months | Delta DHEA, Baseline | 1001.6 ug/dL | Standard Error 183.1 |
| Drospirenone/Ethinyl Estradiol | Delta DHEA at Baseline and 6 Months | Delta DHEA, 6 months | 1092.1 ug/dL | Standard Error 188.4 |
Secondary
DHEAS at Baseline and 6 Months
DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | DHEAS at Baseline and 6 Months | DHEAS, Baseline | 165.4 ug/dL | Standard Error 17 |
| Rosiglitazone | DHEAS at Baseline and 6 Months | DHEAS, 6 months | 160.9 ug/dL | Standard Error 17.9 |
| Drospirenone/Ethinyl Estradiol | DHEAS at Baseline and 6 Months | DHEAS, Baseline | 212.2 ug/dL | Standard Error 25.4 |
| Drospirenone/Ethinyl Estradiol | DHEAS at Baseline and 6 Months | DHEAS, 6 months | 197.5 ug/dL | Standard Error 25.6 |
Secondary
Free Testosterone at Baseline and 6 Months
Free testosterone was measured by equilibrium dialysis.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Free Testosterone at Baseline and 6 Months | Free Testosterone, Baseline | 10.7 pg/mL | Standard Error 2 |
| Rosiglitazone | Free Testosterone at Baseline and 6 Months | Free Testosterone, 6 months | 7.7 pg/mL | Standard Error 1.6 |
| Drospirenone/Ethinyl Estradiol | Free Testosterone at Baseline and 6 Months | Free Testosterone, Baseline | 7.5 pg/mL | Standard Error 0.9 |
| Drospirenone/Ethinyl Estradiol | Free Testosterone at Baseline and 6 Months | Free Testosterone, 6 months | 1.9 pg/mL | Standard Error 0.3 |
Secondary
HDL at Baseline and 6 Months
HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | HDL at Baseline and 6 Months | HDL, Baseline | 42.7 mg/dL | Standard Error 3 |
| Rosiglitazone | HDL at Baseline and 6 Months | HDL, 6 months | 46.1 mg/dL | Standard Error 2.1 |
| Drospirenone/Ethinyl Estradiol | HDL at Baseline and 6 Months | HDL, Baseline | 40.9 mg/dL | Standard Error 1.9 |
| Drospirenone/Ethinyl Estradiol | HDL at Baseline and 6 Months | HDL, 6 months | 55.0 mg/dL | Standard Error 2.8 |
Secondary
Hs-CRP at Baseline and 6 Months
hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Hs-CRP at Baseline and 6 Months | hs-CRP, Baseline | 2.1 mg/L | Standard Error 0.6 |
| Rosiglitazone | Hs-CRP at Baseline and 6 Months | hs-CRP, 6 months | 2.2 mg/L | Standard Error 1 |
| Drospirenone/Ethinyl Estradiol | Hs-CRP at Baseline and 6 Months | hs-CRP, Baseline | 1.7 mg/L | Standard Error 0.5 |
| Drospirenone/Ethinyl Estradiol | Hs-CRP at Baseline and 6 Months | hs-CRP, 6 months | 3.8 mg/L | Standard Error 0.7 |
Secondary
LDL at Baseline and 6 Months
LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | LDL at Baseline and 6 Months | LDL, Baseline | 85.4 mg/dL | Standard Error 7.6 |
| Rosiglitazone | LDL at Baseline and 6 Months | LDL, 6 months | 84.3 mg/dL | Standard Error 7.5 |
| Drospirenone/Ethinyl Estradiol | LDL at Baseline and 6 Months | LDL, Baseline | 85.9 mg/dL | Standard Error 6.2 |
| Drospirenone/Ethinyl Estradiol | LDL at Baseline and 6 Months | LDL, 6 months | 97.7 mg/dL | Standard Error 7.4 |
Secondary
Leptin at Baseline and 6 Months
Leptin was measured by radioimmunoassay.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Leptin at Baseline and 6 Months | Leptin, Baseline | 43.8 ng/mL | Standard Error 4.6 |
| Rosiglitazone | Leptin at Baseline and 6 Months | Leptin, 6 months | 42.7 ng/mL | Standard Error 4.9 |
| Drospirenone/Ethinyl Estradiol | Leptin at Baseline and 6 Months | Leptin, Baseline | 40.6 ng/mL | Standard Error 3.8 |
| Drospirenone/Ethinyl Estradiol | Leptin at Baseline and 6 Months | Leptin, 6 months | 46.8 ng/mL | Standard Error 3.9 |
Secondary
Morning Blood Pressure at Baseline and 6 Months
Morning blood pressure was measured with an automated sphygmomanometer.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Morning Blood Pressure at Baseline and 6 Months | Morning Systolic BP, Baseline | 108.2 mm Hg | Standard Error 2.6 |
| Rosiglitazone | Morning Blood Pressure at Baseline and 6 Months | Morning Diasytolic BP, Baseline | 58.1 mm Hg | Standard Error 2 |
| Rosiglitazone | Morning Blood Pressure at Baseline and 6 Months | Morning Systolic BP, 6 months | 107.5 mm Hg | Standard Error 2.7 |
| Rosiglitazone | Morning Blood Pressure at Baseline and 6 Months | Morning Diastolic BP, 6 months | 58.7 mm Hg | Standard Error 1.2 |
| Drospirenone/Ethinyl Estradiol | Morning Blood Pressure at Baseline and 6 Months | Morning Diastolic BP, 6 months | 59.5 mm Hg | Standard Error 1.2 |
| Drospirenone/Ethinyl Estradiol | Morning Blood Pressure at Baseline and 6 Months | Morning Systolic BP, Baseline | 108.5 mm Hg | Standard Error 3 |
| Drospirenone/Ethinyl Estradiol | Morning Blood Pressure at Baseline and 6 Months | Morning Systolic BP, 6 months | 112.2 mm Hg | Standard Error 2.1 |
| Drospirenone/Ethinyl Estradiol | Morning Blood Pressure at Baseline and 6 Months | Morning Diasytolic BP, Baseline | 58.1 mm Hg | Standard Error 1.7 |
Secondary
Night Blood Pressure at Baseline and 6 Months
Night blood pressure was measured with an automated sphygmomanometer.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Night Blood Pressure at Baseline and 6 Months | Night Systolic BP, Baseline | 117.5 mm Hg | Standard Error 2.8 |
| Rosiglitazone | Night Blood Pressure at Baseline and 6 Months | Night Diastolic BP, Baseline | 63.0 mm Hg | Standard Error 1.5 |
| Rosiglitazone | Night Blood Pressure at Baseline and 6 Months | Night Systolic BP, 6 months | 115.2 mm Hg | Standard Error 2.5 |
| Rosiglitazone | Night Blood Pressure at Baseline and 6 Months | Night Diastolic BP, 6 months | 61.7 mm Hg | Standard Error 1.5 |
| Drospirenone/Ethinyl Estradiol | Night Blood Pressure at Baseline and 6 Months | Night Diastolic BP, 6 months | 62.6 mm Hg | Standard Error 1.1 |
| Drospirenone/Ethinyl Estradiol | Night Blood Pressure at Baseline and 6 Months | Night Systolic BP, Baseline | 112.9 mm Hg | Standard Error 2.1 |
| Drospirenone/Ethinyl Estradiol | Night Blood Pressure at Baseline and 6 Months | Night Systolic BP, 6 months | 116.9 mm Hg | Standard Error 1.9 |
| Drospirenone/Ethinyl Estradiol | Night Blood Pressure at Baseline and 6 Months | Night Diastolic BP, Baseline | 58.6 mm Hg | Standard Error 1.6 |
Secondary
Non-HDL Cholesterol at Baseline and 6 Months
Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Non-HDL Cholesterol at Baseline and 6 Months | Non-HDL cholesterol, Baseline | 65.3 mg/dL | Standard Error 2 |
| Rosiglitazone | Non-HDL Cholesterol at Baseline and 6 Months | Non-HDL cholesterol, 6 months | 62.3 mg/dL | Standard Error 1.9 |
| Drospirenone/Ethinyl Estradiol | Non-HDL Cholesterol at Baseline and 6 Months | Non-HDL cholesterol, Baseline | 70.6 mg/dL | Standard Error 3.5 |
| Drospirenone/Ethinyl Estradiol | Non-HDL Cholesterol at Baseline and 6 Months | Non-HDL cholesterol, 6 months | 87.6 mg/dL | Standard Error 4.4 |
Secondary
Percent Body Fat at Baseline and 6 Months
DXA scans were done to measure the percentage of body fat.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Percent Body Fat at Baseline and 6 Months | Percent body fat, Baseline | 46.2 percentage of body fat | Standard Error 1.1 |
| Rosiglitazone | Percent Body Fat at Baseline and 6 Months | Percent body fat, 6 months | 46.6 percentage of body fat | Standard Error 1.6 |
| Drospirenone/Ethinyl Estradiol | Percent Body Fat at Baseline and 6 Months | Percent body fat, Baseline | 47.3 percentage of body fat | Standard Error 1.1 |
| Drospirenone/Ethinyl Estradiol | Percent Body Fat at Baseline and 6 Months | Percent body fat, 6 months | 48.2 percentage of body fat | Standard Error 1.2 |
Secondary
SHBG at Baseline and 6 Months
SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | SHBG at Baseline and 6 Months | SHBG, Baseline | 28.1 nmol/L | Standard Error 4.6 |
| Rosiglitazone | SHBG at Baseline and 6 Months | SHBG, 6 months | 37.0 nmol/L | Standard Error 6.6 |
| Drospirenone/Ethinyl Estradiol | SHBG at Baseline and 6 Months | SHBG, Baseline | 22.7 nmol/L | Standard Error 2.2 |
| Drospirenone/Ethinyl Estradiol | SHBG at Baseline and 6 Months | SHBG, 6 months | 154.5 nmol/L | Standard Error 24 |
Secondary
Total Fat Mass at Baseline and 6 Months
DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Total Fat Mass at Baseline and 6 Months | Fat mass, Baseline | 44.5 Kg | Standard Error 2.8 |
| Rosiglitazone | Total Fat Mass at Baseline and 6 Months | Fat mass, 6 months | 45.4 Kg | Standard Error 3.4 |
| Drospirenone/Ethinyl Estradiol | Total Fat Mass at Baseline and 6 Months | Fat mass, Baseline | 48.0 Kg | Standard Error 3.2 |
| Drospirenone/Ethinyl Estradiol | Total Fat Mass at Baseline and 6 Months | Fat mass, 6 months | 49.1 Kg | Standard Error 3.4 |
Secondary
Total Testosterone at Baseline and 6 Months
Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Total Testosterone at Baseline and 6 Months | Total Testosterone, Baseline | 45.7 ng/dL | Standard Error 5.6 |
| Rosiglitazone | Total Testosterone at Baseline and 6 Months | Total Testosterone, 6 months | 36.9 ng/dL | Standard Error 3.7 |
| Drospirenone/Ethinyl Estradiol | Total Testosterone at Baseline and 6 Months | Total Testosterone, Baseline | 34.5 ng/dL | Standard Error 3.2 |
| Drospirenone/Ethinyl Estradiol | Total Testosterone at Baseline and 6 Months | Total Testosterone, 6 months | 30.6 ng/dL | Standard Error 3.1 |
Secondary
Triglycerides at Baseline and 6 Months
Triglycerides were measured using the standards of the Centers for Disease Control and Prevention.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosiglitazone | Triglycerides at Baseline and 6 Months | Triglycerides, Baseline | 106.7 mg/dL | Standard Error 8.1 |
| Rosiglitazone | Triglycerides at Baseline and 6 Months | Triglycerides, 6 months | 79.2 mg/dL | Standard Error 6.3 |
| Drospirenone/Ethinyl Estradiol | Triglycerides at Baseline and 6 Months | Triglycerides, Baseline | 148.4 mg/dL | Standard Error 14.8 |
| Drospirenone/Ethinyl Estradiol | Triglycerides at Baseline and 6 Months | Triglycerides, 6 months | 163.5 mg/dL | Standard Error 14.9 |