On Demand Oral Contraception for Obese Women

肥胖女性的按需口服避孕药

基本信息

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
项目类别：
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

项目摘要

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. 项目总结/摘要我们研究的长期目标是为所有女性（正常、超重和肥胖）提供安全、 IG002 是一种有效的、不含雌激素的避孕药替代品。作为一种按需避孕药，在性交前服用。该应用的具体目的是： 1) 提供概念证明，证明 IG002 中两种药物的组合将延迟排卵，特别是在肥胖患者中女性；2) 证明 IG002 的副作用很少且轻微，不存在严重的副作用临床方案将提供证据表明正常月经期间口服 IG002。肥胖女性（BMI ≥30 且 ≤39.9）将排卵延迟至 ≥7 天，而安慰剂则延迟 ≤3 天。优势卵泡在月经周期的卵泡期后期出现，雌二醇不断上升。卵泡开始从垂体释放大量黄体生成素 (LH)，这种 LH 激增作用于脑垂体。优势卵泡在大约 40 小时后导致排卵，这些变化并不容易明显。消费者和/或医疗保健提供者然而，大多数怀孕是在性交期间发生的。排卵日之前的四天或排卵日当天，从而产生五天的窗口期生育能力，LH 激增发生在这五天窗口的中间。在这项概念验证研究中，IG002。分两次服用（间隔 48 小时），第一剂在优势卵泡直径为 17±1.0 mm 该卵泡直径对应于雌二醇升高和 LH 激增的触发时期。当性交可能导致怀孕时。 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。第二种药物开始阻断卵巢内 LH 刺激的重要过程的活动。卵泡，因此在 LH 激增开始后，第二种药物会延迟排卵。在生育窗口期间施用 IG002 的排卵效果优于单独使用任何一种药物。在 LH 激增之前或之后服用时的疗效。 IG002 排卵延迟可防止怀孕 IG002 排卵延迟 ≥7 天将超过妊娠。精子在女性生殖道中的受精能力为5天，但排卵随后发生在女性生殖道中月经周期中重复的性交行为需要重复使用IG002中所含的药物。 IG002 可以改变月经周期间隔，可能会或可能不会导致计划外子宫出血，但否则，预计对健康女性的副作用很小。