Improving emergency contraceptive effectiveness in obese women

提高肥胖女性紧急避孕药的有效性

基本信息

批准号：
9975207
负责人：
ALISON B EDELMAN
金额：
$ 32.48万
依托单位：
OREGON HEALTH & SCIENCE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-12-22 至 2022-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9975207
关键词：
Acetates Affect Blood specimen Body mass index Clinical Management Contraceptive Agents Control Groups Crossover Design Data Development Dose Drug Kinetics Effectiveness Enrollment Estradiol Estrogens Failure Fetus Foundations Future Goals Grant Half-Life Health High-Risk Pregnancy Levonorgestrel Manuscripts Methods Modeling Monitor Obesity Oral Oral Administration Oral Contraceptives Organ Outcome Overweight Ovulation Ovulation Inhibition Pharmaceutical Preparations Pharmacodynamics Placebos Planned Pregnancy Population Pregnancy Pregnancy Complications Pregnant Women Prevention Progesterone Progestins Publishing Randomized Regimen Research Risk Rupture Safety Serum Testing Therapeutic Time Transvaginal Ultrasound Unsafe Sex Woman Work alternative treatment base clinical care clinical practice contraceptive effectiveness dosage emergency contraception experience improved insight pharmacokinetics and pharmacodynamics pill steroid hormone treatment effect treatment strategy unintended pregnancy

项目摘要

PROJECT ABSTRACT Emergency contraception (EC) provides a woman with an additional line of defense against unintended pregnancy following an act of unprotected intercourse. Orally-dosed EC works by delaying ovulation and reduces the risk of pregnancy for a single act of unprotected intercourse by 50-70%. Unfortunately, obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed EC and in some instances EC is equivalent to placebo. Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed EC in obese women. We hypothesize that increasing the dose of orally-dosed EC agents will normalize the pharmacokinetics resulting in the expected treatment effect (delay in follicle rupture) in obese women. In this proposal, we plan to perform detailed pharmacokinetic and pharmacodynamic studies of ulipristal acetate- based EC in obese women and expand upon our preliminary findings of levonorgestrel-based EC.

项目摘要紧急避孕（EC）为女性提供了额外的防线无保护性交行为后意外怀孕。口服EC的作用原理是通过一次无保护性交行为延迟排卵并降低怀孕风险 50-70%。不幸的是，肥胖女性比正常体重指数的女性更有可能同行会经历口服 EC 的失败，并且在某些情况下 EC 相当于安慰剂。我们的初步数据为测试剂量递增策略提供了证据，以努力改善肥胖女性口服 EC 的疗效。我们假设增加口服 EC 药物的剂量将使药代动力学正常化，从而导致肥胖女性的预期治疗效果（延迟卵泡破裂）。在这个提案中，我们计划对醋酸乌利司他进行详细的药代动力学和药效学研究- 基于肥胖女性的 EC 并扩展了我们基于左炔诺孕酮的初步发现欧共体。