Improving Contraceptive Effectiveness in Obese Women

提高肥胖女性的避孕效果

• 批准号: 7937701
• 负责人: ALISON B EDELMAN
• 金额: $ 46.02万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7937701
• 关键词: Age; Animals; Area Under Curve; Binding; Biological Markers; Body mass index; CYP2C9 gene; Cervix Mucus; Cervix Uteri; Characteristics; Contraceptive Agents; Contraceptive Usage; Data; Development; Dose; Drug Kinetics; Enzymes; Epidemic; Epidemiologic Studies; Estradiol; Ethinyl Estradiol; Failure; Fatty acid glycerol esters; Goals; Gonadotropins; Grant; Half-Life; Hepatic; Hormonal; Hormones; Intervention; Life; Measures; Metabolism; Monitor; Obesity; Oral Contraceptives; Organ; Ovarian; Ovarian Ablation; Ovarian hormone; Ovary; Ovulation; Pharmaceutical Preparations; Phenotype; Pituitary Gland; Placebos; Population; Pregnancy; Progesterone; Public Health; Randomized; Regimen; Safety; Sampling; Secondary to; Serum; Sex Hormone-Binding Globulin; Steroids; Testing; Therapeutic; Thrombosis; Time; Ultrasonography; United States; Unplanned pregnancy; Woman; arm; base; cohort; contraceptive effectiveness; contraceptive efficacy; drug clearance; enzyme activity; experience; health economics; hypothalamic pituitary ovarian axis; improved; pill; prevent; reproductive; response; steroid hormone; steroid hormone metabolism; unintended pregnancy

Contraceptive failure is the primary cause of unintended pregnancy in the United States. With obesity rates at epidemic proportions, any association between obesity and strategies that prevent undesired pregnancies constitutes a significant public health and economic concern. Evidence from recent epidemiological studies and our preliminary data (sub-therapeutic levels of steroid hormones due to drug clearance and half-life) suggest that obesity reduces oral contraceptive efficacy. Further studies are necessary to investigate whether these obesity related changes can be resolved. Such an understanding is critical to finding a contraceptive strategy with better efficacy for these women. The overall goal of this grant is to test several intervention strategies in order to reverse obesity-related pharmacokinetic differences in an effort to improve contraceptive efficacy for these women. The main hypothesis for this proposal is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in inadequate hypothalamic-pituitary-ovarian axis suppression during oral contraceptive use in obese women. Reproductive-aged, ovulatory women of obese (BMI >30 kg/m2), will be placed on oral contraceptives for 2 months, then randomized into two intervention arms for an additional 2 months. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (LH, FSH) and ovarian hormone levels (estradiol, progesterone), ovarian follicular activity by ultrasound monitoring, and cervical mucus testing will be monitored.

在美国，避孕失败是意外怀孕的主要原因。肥胖率