METFORMIN VS STANDARD RX FOR HIRSUTISM IN PCOS

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。令人惊讶的是，治疗多囊卵巢综合征女性多毛症的有效性和/或有效性从未被确定！时机到了。这项随机双盲临床试验是第一个基于证据的评估，有足够的能力评估导致患者接受的所有相关结果。这里被指定为“新”的二甲双胍与由口服避孕药或螺内酯组成的“标准疗法”进行了比较。这项提议的具体目标涉及对多毛症、代谢异常以及实际和感知的生活质量的影响。我们强调这些问题对维持遵守很重要。我们关注肥胖对结果的影响。我们谨慎地记录月经出血、副作用和代谢改善方面的差异。经过验证的工具评估生活质量。我们将这些盲目措施的结果与患者的感知进行了对比。每名患者在接受全剂量治疗后每三个月进行一次全面评估，为期一年。对质量控制、主观、半客观和客观的测量有仔细的注意。这项建议的独特之处在于，它解决了对多毛患者最重要的问题，它比较了具有不同预防特征的药物，并提供了迄今为止确定有效性和有效性的最佳机会。该提案将为未来的药物类别和未来用于控制多囊卵巢综合征女性多毛症的药物组合提供基线比较。

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. Suprisingly, the efficacy and/or effectiveness of treatment of hirsutism in women with PCOS have never been determined! The time has come. This randomized double blind clinical trial is the first evidence based evaluation having sufficient power to assess all pertinent outcomes leading to patient acceptance. Metformin designated here as the "new" is compared with "standard therapies" consisting of either an Oral Contraceptive or Spironolactone. The specific aims of this proposal address the impact on hirsutism metabolic aberrations and real and perceived quality of life. We emphasize those issues important in maintaining compliance. We look at the impact of obesity on the outcomes. We are careful to document differences in menstrual bleeding, side effects, and metabolic improvements. Validated instruments assess quality of life. We contrast results of these blinded measures with the patients' perceptions. Each patient is thoroughly evaluated every three months for one year after arriving at full dose therapy. There is careful attention to quality control, subjective, semi-objective, and objective measurements. This proposal is unique in that it addresses those issues most important to hirsute patients, it contrasts agents with different prevention profiles, and it provides the best opportunity to date to determine efficacy as well as effectiveness. The proposal will provide baseline comparisons for future classes of drugs and for future combinations of drugs used to control hirsutism in women with Polycystic Ovary Syndrome.