Expired Study
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Pittsburgh, Pennsylvania 15224


Purpose:

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).


Study summary:

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.


Criteria:

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)


NCT ID:

NCT00640224


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15224
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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