Novel On Demand Female Oral Contraceptive

新型按需女性口服避孕药

基本信息

批准号：
10155056
负责人：
DAVID Fitzgerald ARCHER
金额：
$ 30万
依托单位：
INNOVAGYN, INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-20 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10155056
关键词：
Address Adverse event Affect Age Age-Years Agonist Animals Antral Caliber Childbirth Clinical Protocols Clinical Research Clinical Trials Clinical Trials Design Coitus Collection Combination Medication Contraceptive Agents Contraceptive Availability Contraceptive methods Couples Data Disadvantaged Dose Drug Combinations Drug Interactions Drug Kinetics Enzymes Estrone Estrus Event Exposure to Failure Female Female Condoms Female Contraceptive Agents Fertility Funding Glucuronides Hemorrhage Hormonal Hormones Hour Human Incidence Individual Injections Interruption Intrauterine Devices Investigation Levonorgestrel Life Life Style Longevity Luteinizing Hormone Male Condoms Medical History Menstrual cycle Methods Migraine Nausea Non-Steroidal Anti-Inflammatory Agents Obesity Oocytes Oral Oral Contraceptives Outcome Ovarian Ovulation Participant Pathway interactions Pharmaceutical Preparations Pharmacodynamics Phase Physical Examination Pilot Projects Pituitary Gland Placebos Pregnancy Pregnanediol Progestins Respiratory Diaphragm Risk Safety Serious Adverse Event Signal Transduction Spermatocidal Agents Spottings System Tablets Time Unsafe Sex Urine Vagina Vaginal Diaphragm Vaginal Ring Weight Gain Withdrawal Woman base condoms contraceptive efficacy corpus luteum cost cyclooxygenase 2 egg emergency contraception estrone-3-glucuronide female fertility hormonal contraception implantable device male meloxicam men neglect novel phase II trial pill pleasure preference prevent recruit reproductive reproductive tract sex side effect sperm cell urinary young woman

项目摘要

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.

7。项目摘要/摘要 Innovagyn，Inc。提议在正常月经的妇女中执行2期概念临床试验证明在18至40岁之间，以证明左甲虫加素洛昔康延迟排卵的能力与安慰剂<3天相比，> 7天。这是开发小说《按需女性》的第一步口服避孕。大多数女性激素避孕药可连续暴露于外源激素并且在预防怀孕方面非常有效。男性和男性非荷尔蒙方法，例如男性和雌性避孕套，杀精子，女性膜片和戒断，效果较低，通过中断性行动减少了乐趣。未受保护的性交后使用的紧急避孕功能具有可变功效根据从交往到使用的时间，随后的行为增加了怀孕的发生率性交。所有女性避孕药都有独特的优势和缺点，女性都可以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。平均值美国妇女在生殖生活中使用了四种不同的避孕方法。妇女表明需要谨慎，可以通过性交服用的口服药物有效，副作用有限。 Innovagyn计划开发按需口服平板电脑来解决此未定的需要。我们的产品IG002含有左甲虫，孕激素和非甾体类抗炎的Meloxicam 药物，分别影响两个重要的卵巢途径参与排卵。左甲虫抑制中期垂体叶黄素激素激素激素导致排卵。 Meloxicam抑制环氧合酶2，A 涉及创建卵泡壁隧道的流体内酶排卵。黄体生成激素激素和随后的液内事件发生在女性的窗户期间生育能力，在排卵前的四天。我们的产品影响这两种途径增加避孕功效通过将排卵延迟到精子施肥的5天之外。 IG002与性交可以与单个月经周期中的重复性行为一起使用。这项试验研究将在两次安慰剂中的第一次服用48小时后，评估排卵间隔2 在生育窗户期间排卵的前几天。同一位女士将服用两剂左甲虫同时在随后的月经周期中同时。我们预计Levonorgestrel Plus Meloxicam 与安慰剂<3天相比，将延迟排卵> 7天。这是第一次探索探索功效的临床试验使用每日早晨收集的普通妇女中这种组合药物的多剂量尿液是一种评估尿雌酮-3-葡萄糖醛酸和妊娠二醇-3-的变化的非侵入性方法葡萄糖醛酸葡萄糖剂，黄体 - 粉状转移，作为排卵的证据。