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Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)

Polycystic ovary syndrome (PCOS) is the most common endocrine abnormality in women in the U.S. and is characterized by both reproductive (anovulation and androgen excess) and metabolic dysfunction (insulin resistance). PCOS lacks a simple, safe and effective treatment for women of all ages and all weights. Recently a dietary supplement, inositol, has been used widely to treat women with PCOS. However there are no well designed trials to address the risk/benefit ratio and identify the mechanism of action. In this study we propose a 3 month double blind (of both patients and investigators) randomized controlled trial of inositol supplementation compared to placebo. We hypothesis that women with PCOS who receive inositol supplementation will have a significantly greater reduction in serum total testosterone than women on placebo as well has improvement in glucose tolerance and decrease in fasting insulin.
Amyee McMonagle at amcmonagle@pennstatehealth.psu.edu or 717-531-4484
Female
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Women 18-45 years old
Diagonosed with Polycystic Ovary Sydrome
8 or less periods per year
Periods of greater than or equal to 45 days
Not seeking pregnancy
Exclusion Criteria:
High protactin levels
Uncorrected thyroid disease
Suspected adrenal or ovarian tumor screting androgens
Suspected Cushing's syndrome
Contraindications to the study drug or placebo
Women's Health
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Location
Hershey, PA