Effects of Hypericum Perforatum on Oral Contraceptives

贯叶连翘对口服避孕药的影响

• 批准号: 6411171
• 负责人: PATRICIA A. MURPHY
• 金额: $ 20.13万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-10 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6411171
• 关键词: alternative medicine; blood chemistry; clinical research; clinical trials; cytochrome P450; drug adverse effect; drug interactions; drug metabolism; enzyme activity; ethinyl estradiol; female; graafian follicles; human subject; immunofluorescence technique; luteinizing hormone; medicinal plants; menstrual cycle; norethindrone; oral contraceptives; outcomes research; ovulation; pharmacokinetics; self medication; ultrasonography; urinalysis; women's health; young adult human (21-34)

DESCRIPTION (provided by applicant): This study will evaluate the effects of chronic use of a common herbal remedy, St. John's Wort (Hypericum perforatum) on metabolism of contraceptive steroids and ovarian suppression during oral contraceptive use. St. John's Wort is one of the more popular herbal remedies. It has been implicated as an inducer of the cytochrome P450 enzyme (CYP) system, and as such may cause increased metabolism of certain drugs, including oral contraceptives. Women using oral contraceptives have been warned against using St. John's Wort, although there are to date no data demonstrating risk of contraceptive failure if they do. This will be an open-label, non-randomized, unblinded, sequential treatment clinical trial of reproductive-aged women. Eligible women will take low dose oral contraceptives containing ethinyl estradiol and norethindrone for two months, followed by two months taking the same oral contraceptive and St. John's Wort. Several markers of hormonal and ovarian activity will be evaluated. Parameters to be compared between these two exposure periods are: 1. the pharmacokinetics of contraceptive steroids 2. follicular development in the ovary 3. evidence of ovulation, 4. evidence of the potential for ovulation, 5. the quality of cervical mucus, 6. endometrial proliferation, and 7. irregular vaginal bleeding. This preliminary study will identify possible undesired interactions between a common botanical remedy and oral contraceptives. A concurrent aim is the development and refinement of a methodology for evaluating the risk of ovulation and unintended pregnancy from use of other herbs or medications during oral contraceptive use.

描述（由申请人提供）：本研究将评估以下效果： 长期使用常见草药圣约翰草（贯叶连翘） 口服避孕药期间避孕类固醇代谢和卵巢抑制的影响 避孕药具的使用。圣约翰草是最受欢迎的草药之一。 它被认为是细胞色素 P450 酶 (CYP) 的诱导剂 系统，因此可能会导致某些药物的代谢增加，包括 口服避孕药。警告使用口服避孕药的女性 使用圣约翰草，尽管迄今为止没有数据表明存在以下风险： 如果这样做的话，避孕失败。 这将是一种开放标签、非随机、非盲序贯治疗 育龄妇女的临床试验。符合条件的女性将服用低剂量 含有乙炔雌二醇和炔诺酮的口服避孕药，可供两人服用 几个月，然后两个月服用相同的口服避孕药和圣约翰草。 圣约翰草。荷尔蒙和卵巢活动的几个标志物将被 评价。 这两个曝光周期之间要比较的参数是： 1. 避孕类固醇的药代动力学 2. 卵巢卵泡的发育 3. 排卵证据， 4. 排卵潜力的证据， 5.宫颈粘液的质量， 6.子宫内膜增殖，以及 7.阴道不规则出血。 这项初步研究将确定a之间可能存在的不良相互作用 常见的植物疗法和口服避孕药。一个共同的目标是 开发和完善评估风险的方法 使用其他草药或药物导致排卵和意外怀孕 使用口服避孕药期间。