Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study
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).
Polycystic Ovary Syndrome
Drug: drospirenone/ethinyl estradiol
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on insulin resistance. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Insulin resistance will be assessed by the hyperinsulinemic-euglycemic clamp. In addition glucose tolerance will be assessed using an oral glucose tolerance test
- To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on bone turnover [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]DXA scans and bone turnover markers will be measured at baseline and at completion of the study
- To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on hyperandrogenism [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Hyperandrogenism will be assessed by measuring testosterone level, and the response to a cortrosyn stimulation test at baseline and at completion of the study.
- To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on cardiovascular health and inflammation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Lipid profiles,cardiovascular markers, intima media thickness, pulse wave velocity, and coronary califications using an EBCT will bemeasured at baseline and at conclusion of the study
- To compare the markers of cardiovascular health and inflammation within the PCOS group to those in overweight females without PCOS and lean females without PCOS [ Time Frame: Baseline ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Rosiglitazone
Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone
4 mg daily for 6 months
Other Name: 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 Name: Yasmin
No Intervention: Overweight/Obese without PCOS
Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
No Intervention: Lean without PCOS
Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640224
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15224|
|Principal Investigator:||Silva Arslanian, M.D.||University of Pittsburgh|