On Demand Oral Contraception for Obese Women

肥胖女性的按需口服避孕药

• 批准号: 10699536
• 负责人: DAVID Fitzgerald ARCHER
• 金额: $ 38.24万
• 依托单位: INNOVAGYN, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10699536
• 关键词: Address; Adverse effects; Age; Age Years; Blood; Blood Pressure; Body mass index; Clinical Protocols; Clinical Research; Coitus; Contraceptive Agents; Contraceptive Availability; Contraceptive methods; Couples; Data; Deep Vein Thrombosis; Development; Diameter; Dose; Drug Combinations; Estradiol; Estrogens; Female; Female Contraceptive Agents; Fertility; Gel; Glucuronides; Goals; Health; Health Personnel; Hormonal Oral Contraceptives; Hour; Interruption; Levonorgestrel; Luteinizing Hormone; Medical History; Menstrual cycle; Menstruation; Non-Steroidal Anti-Inflammatory Agents; Obesity; Oocytes; Oral; Oral Contraceptives; Oral cavity; Outcome; Ovarian Follicle; Overweight; Ovulation; Pharmaceutical Preparations; Phase; Physical Examination; Pituitary Hormones; Placebos; Pregnancy; Pregnanediol; Prevention; Process; Progestins; Risk; Risk Factors; Safety; Serious Adverse Event; Serum; Sex Behavior; Tablets; Time; Unsafe Sex; Uterine hemorrhage; Weight; Withdrawal; Woman; comparative efficacy; contraceptive efficacy; corpus luteum; efficacy evaluation; estrone-3-glucuronide; expectation; hormonal contraception; meloxicam; novel; pleasure; prevent; proliferative phase Menstrual cycle; recruit; reproductive tract; satisfaction; side effect; sperm cell; sperm viability; unintended pregnancy; urinary

7. Project Summary/Abstract The long-term goal of our study is to provide all women - normal, overweight, and obese - with a safe, effective, non-estrogen-containing alternative to their current contraceptive options. IG002 is intended for use as an On Demand contraceptive, taken prior to intercourse. The Specific Aims of this application are: 1) provide Proof of Concept that the combination of two drugs in IG002 will delay ovulation specifically in obese women; and 2) demonstrate that side effects from IG002 will be few and mild, with an absence of severe adverse effects. The clinical protocol will provide evidence that IG002 taken orally by normally-menstruating, obese women (BMI ≥30 and ≤39.9) delays ovulation to ≥7 days compared to placebo ≤3 days. A dominant ovarian follicle emerges late in the follicular phase of the menstrual cycle. Rising estradiol from the follicle initiates release of a surge of luteinizing hormone (LH) from the pituitary. This LH surge acts at the dominant ovarian follicle to result in ovulation about 40 hours later. These changes are not readily apparent to the consumer and/or health care provider. However, most pregnancies result when intercourse occurs during the four days preceding the day of ovulation or on the day of ovulation itself, resulting in a five-day window of fertility, with the LH surge occurring in the middle of this five-day window. In this Proof of Concept study, IG002 is taken as two doses (48 hours apart), with the first dose taken when the dominant ovarian follicle diameter is 17±1.0 mm. This follicle diameter corresponds to the period of elevated estradiol and triggering of the LH surge when intercourse is likely to result in pregnancy. IG002 delays ovulation by two mechanisms. One drug prevents the LH surge, but only if taken before the LH surge begins. The second drug blocks the activity of an essential, LH-stimulated process within the ovarian follicle, so the second drug delays ovulation after the LH surge has begun. Each drug alone significantly delays ovulation when administered during the window of fertility. IG002 is superior to either drug alone by providing efficacy when taken either before or after the LH surge. Ovulation delay with IG002 prevents pregnancy. The delay of ovulation with IG002 of ≥7 days will exceed the sperm fertilizing capacity of 5 days in the female reproductive tract, but ovulation occurs subsequently in the menstrual cycle. Repeated acts of intercourse will require repeated use of IG002. The drugs contained in IG002 can alter the menstrual cycle interval and may or may not cause unscheduled uterine bleeding, but otherwise minimal side effects are anticipated in healthy women.

7。项目摘要/摘要 我们研究的长期目标是为所有妇女（正常，超重和肥胖）提供安全，安全 有效的，非雌激素的替代替代其当前的避孕措施。 IG002旨在使用 作为一种按需避孕药，在性交之前采取。本应用程序的具体目的是： 1）提供概念证明，IG002中两种药物的组合将在肥胖中特别延迟排卵 女性; 2）证明IG002的副作用将很少且温和，没有严重 不利影响。临床方案将提供证据，表明IG002通过正常次审查，口服口服， 肥胖女性（BMI≥30和≤39.9）与安慰剂≤3天相比，排卵迟到≥7天。 在月经周期的卵泡阶段后期出现了主要的卵巢卵泡。雌二醇的上升 Folicle启动了垂体中释放出亮叶马龙（LH）的激增。这种LH激增在 大约40小时后，主要的卵巢卵泡导致排卵。这些更改并不明显 消费者和/或医疗保健提供者。但是，当性交发生在 排卵的那天或排卵天本身的四天，导致了五天的窗口 生育能力，LH激增发生在这个为期五天的窗口的中间。在此概念研究证明中，IG002 被视为两剂（相距48小时），当占主导卵巢叶直径为 17±1.0毫米。该植物直径对应于雌二醇升高的时期和LH激增的触发 当性交可能导致怀孕。 IG002通过两种机制延迟排卵。一种药物可以防止LH激增，但前提是在LH之前服用 激增开始。第二种药物阻止了卵巢中必不可少的LH刺激过程的活性 卵泡，因此第二种药物在LH激增开始后延迟排卵。每种药物都会显着延迟 在生育窗口期间进行排卵。通过提供IG002，IG002仅优于任何一种药物 LH激增前或之后采取的功效。 IG002的排卵延迟可防止怀孕。 Ig002≥7天排卵的延迟将超过 女性生殖道的精子施肥5天，但排卵随后发生在 月经周期。重复的性交将需要重复使用IG002。包含的药物 IG002可以改变月经间隔，可能会或可能不会引起未定的子宫出血，但是 否则，健康女性预计会产生最小的副作用。