Status:
COMPLETED
Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study
Lead Sponsor:
Silva Arslanian
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
10-20 years
Phase:
PHASE4
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 mar...
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/hyperinsulinemi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00640224
Start Date
March 1 2005
End Date
July 1 2015
Last Update
November 17 2017
Active Locations (1)
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1
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224