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. Although oral contraceptives are the mainstay in the treatment of polycystic ovary syndrome (PCOS), several lines of evidence support a role for the use of insulin lowering therapies in these women. This latter 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. 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 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 detailed evaluation at baseline and at the end of 4 months. Simple safety evaluations will be performed at 4 weeks and 10 weeks. Study measures will fall into two main groups: reproductive and metabolic.
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