Novel On Demand Female Oral Contraceptive

7.项目摘要/摘要 Innova Gyn，Inc.建议对月经正常的妇女进行第二阶段概念验证临床试验 在18至40岁之间证明左旋诺孕酮和美洛昔康通过以下方式延迟排卵的能力 &gt；7天，而安慰剂为&lt；3天。这是发展一部按需女性小说的开始 口服避孕药。大多数女性荷尔蒙避孕药持续接触外源激素 在预防怀孕方面非常有效。女性和男性的非激素方法，如男性和 女用避孕套、杀精剂、女用避孕套和避孕套的效果较差，而且是通过干扰性行为来实现的 行动会减少快乐。在无保护措施的性交后使用的紧急避孕措施有不同的效果 根据从性交到使用的时间，并在随后的行为中怀孕的发生率增加 性交。所有女性避孕药都有独特的优点和缺点，妇女能够 根据他们的个人喜好和当前的生活方式从一种方法切换到另一种方法。平均水平 美国一名妇女在生育过程中使用了四种不同的避孕方法。 女性表示需要一种谨慎的口服药物，这种药物可以在性交时服用，也就是 有效，副作用有限。Innova Gyn计划开发一种按需口服药片来解决这一未得到满足的问题 需要。我们的产品IG002含有左旋孕酮和美洛昔康，这是一种非类固醇抗炎药。 药物，分别影响与排卵有关的两条重要的卵巢途径。左旋诺孕酮抑制血管紧张素转换 周期中期，脑下垂体促黄体激素激增，导致排卵。美洛昔康抑制环氧合酶-2和 卵泡内酶，参与创建卵泡壁隧道，卵母细胞(卵子)在该隧道中挤出 排卵。黄体生成素激增和随后的卵泡内事件发生在女性的窗口期 排卵前四天和排卵当天的受孕率。我们的产品对这两条路径的影响越来越大 避孕效果通过推迟排卵超过5天的精子受精能力。IG002与 性交可以在一个月经周期内与重复的性交行为一起使用。这项初步研究将 评估两剂安慰剂中的第一剂相隔48小时服用后至排卵的间隔时间 在生育窗口期排卵前的天数。同一名妇女将服用两剂左旋诺孕酮加 在随后的月经周期中同时服用美洛昔康。我们预计左旋诺孕酮加美洛昔康 与安慰剂3天相比，排卵延迟7天。这是第一次临床试验，以探索其疗效 这种多剂量联合用药在正常女性中每天清晨收集排尿 尿作为一种非侵入性方法评估尿雌酮-3-葡萄糖醛酸苷和孕二醇-3- 葡萄糖醛酸苷，黄体-卵泡移位，作为排卵的证据。

7. Project Summary/Abstract InnovaGyn, Inc. proposes to perform a Phase 2 Proof of Concept clinical trial in normal menstruating women between 18 to 40 years of age to demonstrate the ability of levonorgestrel plus meloxicam to delay ovulation by >7 days compared to placebo of <3 days. This is the beginning step in developing a novel On Demand female oral contraceptive. Most female hormonal contraceptives provide continuous exposure to exogenous hormones and are highly effective in preventing pregnancy. Female and male non-hormonal methods such as male and female condoms, spermicides, female diaphragms and withdrawal, are less effective and by interrupting the sex act diminish pleasure. Emergency contraception, used after unprotected intercourse, has a variable efficacy based on the time from intercourse to use and has an increased incidence of pregnancy with subsequent acts of intercourse. All female contraceptives have unique advantages and disadvantages and women are able to switch from one method to another depending upon their personal preferences and current life style. The average US woman uses four different contraceptive methods during her reproductive life. Women have indicated a need for a discreet, oral medication that can be taken with intercourse, that is effective and has limited side effects. InnovaGyn plans to develop a On Demand oral tablet to address this unmet need. Our product IG002 contains levonorgestrel, a progestin, plus meloxicam, a non-steroidal anti-inflammatory drug, that individually affect two important ovarian pathways involved in ovulation. Levonorgestrel inhibits the mid-cycle pituitary luteinizing hormone surge that results in ovulation. Meloxicam inhibits cyclooxygenase-2, an intrafollicular enzyme that is involved in creating the follicle wall tunnel where the oocyte (egg) is extruded at ovulation. The luteinizing hormone surge and subsequent intrafollicular events occur during the window of female fertility, the four days prior to and day of ovulation. Our product affects these two pathways increasing contraceptive efficacy by delaying ovulation beyond the 5 days of sperm fertilizing capacity. IG002 taken with intercourse can be used with repetitive acts of intercourse in a single menstrual cycle. This Pilot Study will evaluate the interval to ovulation following the first of two doses of placebo taken 48 hours apart administered 2 days before ovulation during the window of fertility. The same woman will take two doses of levonorgestrel plus meloxicam at the same time in a subsequent menstrual cycle. We anticipate that levonorgestrel plus meloxicam will delay ovulation >7 days compared to placebo <3 days. This is the first clinical trial to explore the efficacy of multiple doses of this combination medication in normal women using the collection of daily morning voided urines as a non-invasive method to assess changes in urinary estrone-3-glucuronide and pregnandiol-3- glucuronide, the luteal-follicular shift, as evidence of ovulation.