PIOGLITAZONE & ETHINYL ESTRADIOL/DROSPERINONE IN THE TREATMENT OF PCOS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Polycystic ovary syndrome (PCOS) affects 5-8% of women in the United States. Women with PCOS are more insulin resistant than weight-matched control women and have exceptionally high rates of early-onset impaired glucose tolerance and type 2 diabetes, as well as a substantially elevated risk for hypertension, dyslipidemia, coronary, and other vascular diseases. Although oral contraceptives are the mainstay in the treatment of PCOS, several lines of evidence support a role for insulin lowering therapies in these women. This form of treatment has been demonstrated to ameliorate the reproductive and metabolic derangements of PCOS and to reduce the risk for development of type 2 diabetes in non-PCOS populations. Thus, the key aims of the proposed study are to determine: 1. if pioglitazone (Actos¿) is superior to an oral contraceptive (Yasmin¿) in amelioration of the reproductive and metabolic aberrations of PCOS; 2. to determine if the combination of Actos¿ plus Yasmin¿ is superior to either agent alone in amelioration of the reproductive and metabolic aberrations of PCOS. A randomized, double-blind, double dummy study design will be utilized. Subjects will be randomized to treatment with Yasmin¿ + placebo, Actos¿ + placebo, or Actos¿ + Yasmin¿. This treatment will continue for 4 months. Subjects will undergo evaluation at baseline and at the end of 4 months. Study measures will fall into two main groups: reproductive and metabolic. The following groupwise comparisons will be obtained at the end of the treatment period: Yasmin¿ vs Actos¿, Yasmin¿ vs. Acto¿s + Yasmin¿, Actos¿ vs. Actos¿ + Yasmin¿.