Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

Completed · Phase 4

Conditions studied: Polycystic Ovary Syndrome

In brief

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).

Key facts

Study ID

NCT00640224

Run by

Silva Arslanian

People needed

65

Starts

2005-03-01

Expected to finish

2015-07-01

Last updated by the study team

2017-11-17

Who can join

Age: 10 and older, up to 20. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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