POSTMENOPAUSAL ESTROGEN/PROGESTIN INTERVENTIONS

PEPI试验是一种重要的方法， 明确的方式可能，代谢和临床效果 绝经后妇女的雌激素/孕激素组合。 这项前瞻性随机临床试验将是其最大的 等结果出来的时候 它可以形成 未来甚至更大规模研究的框架， 雌激素/孕酮对疾病结果的影响， 心血管 根据这一观点，PEPI试验假设 非常重要。 我们设计了一项临床试验，比较了两种形式的 雌激素制剂：结合马雌激素（CEE）和 经皮雌二醇（TDE）;并比较了两种形式的 孕激素：醋酸甲羟孕酮（MPA）和微粉化 孕酮（P）。 第一，绝经后女性， 将子宫随机分为6组：CEE + MPA组，CEE + P组， TDE + MPA; TDE + P;安慰剂贴剂+安慰剂药丸;安慰剂药丸+ 安慰剂 然后我们可以比较不同的 孕激素在女性相同的雌激素，并比较 不同雌激素对同一雌激素的影响。 我们 也可以将每组与安慰剂组进行比较。 第二、 将无子宫的绝经后女性随机分为3组 组; CEE、TDE、安慰剂（1/2贴剂）。 从这个群体中，我们可以 将雌激素的作用仅与添加 例如，CEE + MPA vs VEE，等等，雌激素只针对 安慰剂，以及不同的雌激素制剂之间。 这 允许代谢和临床结果的多重比较 变量 研究人员对PEPI试验感到兴奋并致力于此 因为它对健康的重要性。 我们的经验相当丰富 在以下领域：（1）临床试验方案制定， 招聘、维护和数据质量;（2）建立 基于人群的骨密度测量标准数据; (3)一个功能齐全的脂质研究诊所护理的存在 脂质实验室和主要研究者， 血脂紊乱的管理;（4）心理学研究 （五）疾病的发生;（六）疾病的发生;（七）疾病的发生。 率流行病学计划。

The PEPI Trial is an important method of establishing, in as unambiguous a manner possible, the metabolic and clinical effects of estrogen/progestin combinations in post-menopausal women. This prospective randomized clinical trial will be the largest of its kind when the results are finally available. It may form the framework for a future and even larger study, regarding the effects of estrogen/progestin on disease outcome e.g., cardiovascular. Taken with this view the PEPI Trial assumes great importance. We have designed a clinical trial that compares two forms of estrogen preparations: Conjugated equine estrogen (CEE) and transdermal estradiol (TDE); and compares two forms of progestins: Medroxyprogesterone acetate (MPA) and micronized progesterone (P). First, post-menopausal women with intact uterus will be randomized to 6 groups: CEE + MPA; CEE + P; TDE + MPA; TDE + P; placebo patch + placebo pill; placebo pill + placebo pill. We can then compare the effect of different progestins in women on the same estrogen, and compare the effect of different estrogens in women on the same progestin. We can also compare each group against the placebo group. Second, past-menopausal women without uterus will be randomized of 3 groups; CEE, TDE, placebo (1/2 patch). From this group we can compare the effects of estrogen only to those with added progestin e.g., CEE + MPA vs VEE, and etc., estrogen only against placebo, and between the different estrogen preparations. This allows multiple comparisons of metabolic and clinical outcome variables. The investigators are excited and committed to the PEPI Trial because of its health importance. Our experience is considerable in the following areas: (1) Clinical trial protocol development, recruitment, maintenance and data quality; (2) establishment of population based normative data for bone density measurements; (3) presence of a fully functioning Lipid Research Clinic Care Lipid Laboratory and principal investigator interested in management of lipid disorders; (4) research in the psychological and sexual responses to illnesses; and (5) the presence of a first- rate epidemiological program.