PIOGLITAZONE & ETHINYL ESTRADIOL/DROSPERINONE IN THE TREATMENT OF PCOS

吡格列酮

• 批准号: 7604775
• 负责人: DAVID A EHRMANN
• 金额: $ 0.62万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604775
• 关键词: Affect; Computer Retrieval of Information on Scientific Projects Database; Coronary; Development; Double-Blind Method; Dyslipidemias; Ethinyl Estradiol; Evaluation; Funding; Grant; Hypertension; Institution; Insulin; Insulin Resistance; Measures; Metabolic; Non-Insulin-Dependent Diabetes Mellitus; Oral Contraceptives; Pioglitazone; Placebos; Polycystic Ovary Syndrome; Population; Randomized; Rate; Research; Research Design; Research Personnel; Resources; Risk; Role; Source; Takeda brand of pioglitazone hydrochloride; United States; United States National Institutes of Health; Vascular Diseases; Weight; Woman; Yasmin; early onset; falls; impaired glucose tolerance; reproductive; treatment duration

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¿.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以出现在其他 CRISP 条目中 列出的机构是。 对于中心来说，它不一定是研究者的机构。 多囊卵巢综合症 (PCOS) 影响美国 5-8% 的女性，患有 PCOS 的女性比体重匹配的对照女性更容易产生胰岛素抵抗，并且早发性糖耐量受损和 2 型糖尿病的发病率也极高。尽管口服避孕药是治疗多囊卵巢综合征的主要方法，但一些证据支持降胰岛素疗法在这些疾病中的作用。这种治疗形式已被证明可以改善 PCOS 的生殖和代谢紊乱，并降低非 PCOS 人群患 2 型糖尿病的风险。因此，本研究的主要目的是确定： 1. 2. 确定吡格列酮（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¿）；加亚斯明??在改善 PCOS 的生殖和代谢异常方面优于单独使用任何一种药物。将采用随机、双盲、双模拟研究设计。受试者将被随机分配接受 Yasmin 治疗。 + 安慰剂，Actos¿ + 安慰剂，或 Actos¿ + 亚斯明¿该治疗将持续 4 个月，受试者将在 4 个月结束时接受评估，研究指标将分为两个主要组：治疗期结束时将获得以下分组比较：亚斯明·与阿克托斯相比?? ，亚斯明??与阿克托相比?? s + 亚斯明¿ ，阿克托斯??与阿克托斯相比¿ + 亚斯明¿ 。