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| ID | Type | Description | Link |
|---|---|---|---|
| 2K24HD001357 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory markers, vascular markers and bone development in overweight adolescent females with polycystic ovary syndrome (PCOS).
The purpose of this study is to:
1) to compare effects of treatment with drospirenone/ethinyl estradiol (Yasmin)versus rosiglitazone (Avandia) on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover.
OCPs are the first-line therapy for PCOS, however, they do not address the insulin resistance or the inflammation. Insulin sensitizers have been used successfully to treat PCOS but thiazolidinediones such as rosiglitazone have not been used in adolescents. Therefore we will investigate the effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone in overweight adolescents with PCOS. We will obtain comprehensive evaluations before and 6 months after randomization, to the respective treatment arms to determine the differences between the 2 treatment modalities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosiglitazone | Active Comparator | Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone |
|
| Drospirenone/ethinyl estradiol | Active Comparator | Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol |
|
| Overweight/Obese without PCOS | No Intervention | Overweight adolescent females without PCOS to use as comparison of normal developmental changes. *No participants were enrolled in this Arm. | |
| Lean without PCOS | No Intervention | Lean healthy girls without PCOS to serve as controls for the cardiovascular markers. *No participants were enrolled in this Arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rosiglitazone | Drug | 4 mg daily for 6 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Insulin Sensitivity at Baseline and 6 Months. | Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp. | Baseline and 6 months |
| Hepatic Insulin Sensitivity at Baseline and 6 Months. | Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp. | Baseline and 6 months |
| Glucose Tolerance Status at Baseline and 6 Months. | Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Fat Mass at Baseline and 6 Months | DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass. | Baseline and 6 months |
| Total Testosterone at Baseline and 6 Months | Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silva Arslanian, M.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21325466 | Result | Tfayli H, Ulnach JW, Lee S, Sutton-Tyrrell K, Arslanian S. Drospirenone/ethinyl estradiol versus rosiglitazone treatment in overweight adolescents with polycystic ovary syndrome: comparison of metabolic, hormonal, and cardiovascular risk factors. J Clin Endocrinol Metab. 2011 May;96(5):1311-9. doi: 10.1210/jc.2010-2547. Epub 2011 Feb 16. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rosiglitazone | Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months |
| FG001 | 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 |
| FG002 | Overweight/Obese Without PCOS | Overweight adolescent females without PCOS to use as comparison of normal developmental changes. |
| FG003 | Lean Without PCOS | Lean healthy girls without PCOS to serve as controls for the cardiovascular markers |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rosiglitazone | Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months |
| BG001 | Drospirenone/Ethinyl Estradiol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peripheral Insulin Sensitivity at Baseline and 6 Months. | Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp. | Posted | Mean | Standard Error | mg/kg/min per uU/mL | Baseline and 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rosiglitazone | Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone rosiglitazone: 4 mg daily for 6 months |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Silva Arslanian | Children's Hospital of Pittsburgh of UPMC | 412-692-6935 |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| C534342 | drospirenone and ethinyl estradiol combination |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| drospirenone/ethinyl estradiol | Drug | 1 tab (3mg/30mcg) daily for 6 months |
|
|
| Baseline and 6 months |
| Percent Body Fat at Baseline and 6 Months | DXA scans were done to measure the percentage of body fat. | Baseline and 6 months |
| Free Testosterone at Baseline and 6 Months | Free testosterone was measured by equilibrium dialysis. | Baseline and 6 months |
| SHBG at Baseline and 6 Months | SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay. | Baseline and 6 months |
| DHEAS at Baseline and 6 Months | DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis. | Baseline and 6 months |
| Delta Androstenedione at Baseline and 6 Months | Delta Androstenedione was measured by HPLC-tandem mass spectroscopy. | Baseline and 6 months |
| Delta DHEA at Baseline and 6 Months | Delta DHEA was measured by HPLC-tandem mass spectroscopy. | Baseline and 6 months |
| Delta 17-OHProg at Baseline and 6 Months | Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy. | Baseline and 6 months |
| Delta 17-OHPreg at Baseline and 6 Months | Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy. | Baseline and 6 months |
| Cholesterol at Baseline and 6 Months | Cholesterol was measured using the standards of the Centers for Disease Control and Prevention. | Baseline and 6 months |
| HDL at Baseline and 6 Months | HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention. | Baseline and 6 months |
| LDL at Baseline and 6 Months | LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention. | Baseline and 6 months |
| Triglycerides at Baseline and 6 Months | Triglycerides were measured using the standards of the Centers for Disease Control and Prevention. | Baseline and 6 months |
| Non-HDL Cholesterol at Baseline and 6 Months | Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention. | Baseline and 6 months |
| Adiponectin at Baseline and 6 Months | Adiponectin was measured by radioimmunoassay. | Baseline and 6 months |
| Leptin at Baseline and 6 Months | Leptin was measured by radioimmunoassay. | Baseline and 6 months |
| Hs-CRP at Baseline and 6 Months | hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry. | Baseline and 6 months |
| Morning Blood Pressure at Baseline and 6 Months | Morning blood pressure was measured with an automated sphygmomanometer. | Baseline and 6 months |
| Night Blood Pressure at Baseline and 6 Months | Night blood pressure was measured with an automated sphygmomanometer. | Baseline and 6 months |
| Withdrawal by Subject |
|
| Headaches |
|
Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol
drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months
| BG002 | Overweight/Obese Without PCOS | Overweight adolescent females without PCOS to use as comparison of normal developmental changes. |
| BG003 | Lean Without PCOS | Lean healthy girls without PCOS to serve as controls for the cardiovascular markers |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Overweight/Obese Without PCOS |
Overweight adolescent females without PCOS to use as comparison of normal developmental changes. |
| OG003 | Lean Without PCOS | Lean healthy girls without PCOS to serve as controls for the cardiovascular markers |
|
|
| Primary | Hepatic Insulin Sensitivity at Baseline and 6 Months. | Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp. | Posted | Mean | Standard Error | (mg/kg/min x uU/mL)-1 | Baseline and 6 months |
|
|
|
| Primary | Glucose Tolerance Status at Baseline and 6 Months. | Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria. | Posted | Count of Participants | Participants | Baseline and 6 months |
|
|
|
| Secondary | Total Fat Mass at Baseline and 6 Months | DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass. | Posted | Mean | Standard Error | Kg | Baseline and 6 months |
|
|
|
| Secondary | Total Testosterone at Baseline and 6 Months | Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy. | Posted | Mean | Standard Error | ng/dL | Baseline and 6 months |
|
|
|
| Secondary | Percent Body Fat at Baseline and 6 Months | DXA scans were done to measure the percentage of body fat. | Posted | Mean | Standard Error | percentage of body fat | Baseline and 6 months |
|
|
|
| Secondary | Free Testosterone at Baseline and 6 Months | Free testosterone was measured by equilibrium dialysis. | Posted | Mean | Standard Error | pg/mL | Baseline and 6 months |
|
|
|
| Secondary | SHBG at Baseline and 6 Months | SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay. | Posted | Mean | Standard Error | nmol/L | Baseline and 6 months |
|
|
|
| Secondary | DHEAS at Baseline and 6 Months | DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis. | Posted | Mean | Standard Error | ug/dL | Baseline and 6 months |
|
|
|
| Secondary | Delta Androstenedione at Baseline and 6 Months | Delta Androstenedione was measured by HPLC-tandem mass spectroscopy. | Posted | Mean | Standard Error | ng/dL | Baseline and 6 months |
|
|
|
| Secondary | Delta DHEA at Baseline and 6 Months | Delta DHEA was measured by HPLC-tandem mass spectroscopy. | Posted | Mean | Standard Error | ug/dL | Baseline and 6 months |
|
|
|
| Secondary | Delta 17-OHProg at Baseline and 6 Months | Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy. | Posted | Mean | Standard Error | ng/dL | Baseline and 6 months |
|
|
|
| Secondary | Delta 17-OHPreg at Baseline and 6 Months | Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy. | Posted | Mean | Standard Error | ng/dL | Baseline and 6 months |
|
|
|
| Secondary | Cholesterol at Baseline and 6 Months | Cholesterol was measured using the standards of the Centers for Disease Control and Prevention. | Posted | Mean | Standard Error | mg/dL | Baseline and 6 months |
|
|
|
| Secondary | HDL at Baseline and 6 Months | HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention. | Posted | Mean | Standard Error | mg/dL | Baseline and 6 months |
|
|
|
| Secondary | LDL at Baseline and 6 Months | LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention. | Posted | Mean | Standard Error | mg/dL | Baseline and 6 months |
|
|
|
| Secondary | Triglycerides at Baseline and 6 Months | Triglycerides were measured using the standards of the Centers for Disease Control and Prevention. | Posted | Mean | Standard Error | mg/dL | Baseline and 6 months |
|
|
|
| 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. | Posted | Mean | Standard Error | mg/dL | Baseline and 6 months |
|
|
|
| Secondary | Adiponectin at Baseline and 6 Months | Adiponectin was measured by radioimmunoassay. | Posted | Mean | Standard Error | ug/mL | Baseline and 6 months |
|
|
|
| Secondary | Leptin at Baseline and 6 Months | Leptin was measured by radioimmunoassay. | Posted | Mean | Standard Error | ng/mL | Baseline and 6 months |
|
|
|
| Secondary | Hs-CRP at Baseline and 6 Months | hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry. | Posted | Mean | Standard Error | mg/L | Baseline and 6 months |
|
|
|
| Secondary | Morning Blood Pressure at Baseline and 6 Months | Morning blood pressure was measured with an automated sphygmomanometer. | Posted | Mean | Standard Error | mm Hg | Baseline and 6 months |
|
|
|
| Secondary | Night Blood Pressure at Baseline and 6 Months | Night blood pressure was measured with an automated sphygmomanometer. | Posted | Mean | Standard Error | mm Hg | Baseline and 6 months |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 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 | 0 | 20 | 0 | 20 |
| EG002 | Overweight/Obese Without PCOS | Overweight adolescent females without PCOS to use as comparison of normal developmental changes. | 0 | 0 | 0 | 0 |
| EG003 | Lean Without PCOS | Lean healthy girls without PCOS to serve as controls for the cardiovascular markers | 0 | 0 | 0 | 0 |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Normal glucose tolerance, 6 months |
|
| Impaired glucose tolerance, 6 months |
|
| Morning Systolic BP, 6 months |
|
| Morning Diastolic BP, 6 months |
|
| Night Systolic BP, 6 months |
|
| Night Diastolic BP, 6 months |
|