HORMONE REPLACEMENT THERAPY--PROGESTERONE SKIN CREAM

本项目的目标是开发新的黄体酮 作为激素替代疗法有效的制剂-- 保护冠状动脉免受高反应性的影响。如此高- 反应性的结果从缺乏孕激素后， 卵巢功能停止。期待中的新产品，有待验证 在这里可行，在第二阶段开发，并在第三阶段销售， 绝经后妇女可以接受的配方 足够好，以允许大多数人遵守 开始激素替代疗法--持续50年甚至 更多.孕酮对心血管系统的保护作用 可以预期在孕酮后2周内丢失 下降;因此，黄体酮应提供的形式， 可以预期的遵守。 该护肤霜制剂被女性广泛接受，并且具有最佳的 每日一次治疗的药代动力学， 心血管事件，包括缺血性心脏病和冠心病 血管痉挛尽管心血管疾病导致的死亡风险 在绝经后妇女中，这一比例接近50%， 其他风险，目前可用的激素替代疗法 既不容易理解，也不容易接受。 拟定商业应用： 商业应用将是一种经皮制剂， 含有吸收促进剂的孕酮， 使患心血管疾病的风险降到最低的血液水平。的 产品有望在激素领域得到广泛应用 替代疗法，从而提高患者的接受度， 一个巨大的增长市场。

The objective of this project is to develop new progesterone formulation(s) that are effective as hormone replacement therapy-- protecting the coronary arteries against hyperreactivity. Such hyper- reactivity results from the deficiency of progesterone after the cessation of ovarian function. The anticipated new product, to be proved feasible here, developed in phase 2, and marketed in phase 3, will be a formulation that will be accepted by post-menopausal women sufficiently well to allow compliance of the majority of those who initiate hormone replacement therapy--for durations of 50 years or even more. Protection provided by progesterone for the cardiovascular system can be expected to be lost in a matter of 2 weeks after progesterone declines; therefore progesterone should be provided in a form with which compliance can be expected. The skin cream formulation is well accepted by women, and has optimal pharmacokinetics for a once a day treatment that will reduce the risk of cardiovascular events including ischemic heart disease and coronary vasospasm. Even though the risk of death due to cardiovascular causes is nearly 50% for post-menopausal women, and is far greater than any other risk, the presently available forms of hormone replacement therapy are neither well understood nor readily accepted. PROPOSED COMMERCIAL APPLICATION: The commercial application will be a percutaneous formulation of progesterone with absorption enhancers comprising a method to produce a blood level that minimizes the risk of cardiovascular disease. The product is anticipated to find widespread application in hormone replacement therapy, resulting in improved patient acceptance, and thus a large growing market.