PIOGLITAZONE & ETHINYL ESTRADIOL/DROSPERINONE IN THE TREATMENT OF PCOS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 多囊卵巢综合征(PCOS)影响着美国5%-8%的女性。与体重匹配的对照组女性相比，患有多囊卵巢综合征的女性胰岛素抵抗更严重，早发性糖耐量受损和2型糖尿病的发生率极高，高血压、血脂异常、冠状动脉和其他血管疾病的风险显著增加。虽然口服避孕药是治疗多囊卵巢综合征的主要手段，但有几条证据支持降低胰岛素治疗在这些妇女中的作用。这种形式的治疗已被证明可以改善多囊卵巢综合征的生殖和代谢紊乱，并降低非多囊卵巢综合征人群中发生2型糖尿病的风险。因此，本研究的主要目的是确定：1.吡格列酮(Actos？)在改善PCOS的生殖和代谢异常方面是否优于口服避孕药(Yasmin？)；2.确定Actos？和Yasmin？联合用药在改善PCOS的生殖和代谢异常方面是否优于任何一种药物。将采用随机、双盲、双模拟研究设计。受试者将随机接受雅司明+安慰剂、Actos+安慰剂或Actos+Yasmin的治疗。这项治疗将持续4个月。受试者将在基线和4个月结束时接受评估。研究措施将分为两大类：生殖和新陈代谢。GroupWise将在疗程结束时进行以下比较：雅思明与Actos、雅思明与Acto、S+雅思明、Actos与Actos+Yasmin。

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¿.