Feasibility and Safety of Vaginal Administration of 17-hydroxyprogesterone caproate

项目摘要--试点项目 己酸17-羟孕酮阴道给药的可行性和安全性 在这项初步研究中，我们建议开发一种17-羟孕酮己酸酯(17-羟孕酮-己酸酯)的阴道制剂。 OHPC)。我们将首先制定一种17-OHPC的制剂，并在兔身上进行测试，以确保其耐受性。 一旦显影，我们将确定有多少化合物进入循环。然后我们将测试 在非怀孕妇女的配方中，并测量到达血液的药物的量。一旦我们有了 证明该制剂对女性耐受性良好，我们可以研究该制剂对药物的影响 对孕激素作出反应并最终在怀孕期间测试配方的那些基因 现在通过注射接受这种药物治疗的妇女。我们假设阴道准备将是 耐受性比注射更好，即使不是更有效，也同样有效。

PROJECT SUMMARY– PILOT PROJECT Feasibility and Safety of Vaginal Administration of 17-hydroxyprogesterone Caproate In this pilot study we are proposing to develop a vaginal formulation of 17-hydroxyprogesterone caproate (17- OHPC). We will first formulate a preparation of 17-OHPC that will be tested in rabbits to assure its tolerability. Once developed, we will determine how much of the compound enters the circulation. We will then test the formulation in non-pregnant women and measure the amount of medication reaching the blood. Once we have demonstrated that the preparation is well tolerated by women, we can the study the impact of the medication on those genes that respond to the progesterone hormone and eventually test the formulation in pregnant women who are now receiving this medication by injection. We postulate that the vaginal preparation will be better tolerated than injections and will be as effective if not more so.