Overweight, Polycystic Ovary Syndrome, and Bone Research Study - NCT00640224-15213(Clinical Trial 210336)
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Pittsburgh |
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State:
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PA |
| Zip Code: |
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15213 |
| Conditions: |
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Polycystic Ovary Syndrome |
| Purpose: |
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The purpose is to investigate effects of 2 different treatments (drospirenone/ethinyl
estradiol versus rosiglitazone) on the bone development, vascular markers, inflammatory
markers, insulin sensitivity and androgen levels of overweight adolescent females with
polycystic ovary syndrome (PCOS).
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| Study summary: |
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The purpose of this study is to:
1) to compare effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone
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: |
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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) |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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