评估药物和口服避孕药相互作用研究中的排卵风险。

N de la Rey, R Schall, H G Luus, B H Meyer, F O Müller
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引用次数: 0

摘要

当某些药物与口服避孕药同时服用时,避孕药的功效可能会减弱,并可能导致怀孕。由于口服避孕药的功能是抑制排卵,因此排卵风险是临床研究药物与口服避孕药相互作用的重要参数。本文的目的是比较一种交叉设计和一种用于评估药物和口服避孕药之间可能相互作用的新研究设计,并讨论在规划和评估此类研究结果时涉及的统计问题。
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Assessing the risk of ovulation in interaction studies of drugs and oral contraceptives.

When certain drugs are taken concomitantly with an oral contraceptive, the efficacy of the contraceptive may be obtunded, and pregnancy may ensue. Since the function of oral contraceptives is to suppress ovulation, the risk of ovulation is an important parameter in clinical studies investigating interactions between drugs and oral contraceptives. The purpose of this paper is to compare a crossover design, and a new study design used for assessing a possible interaction between a drug and an oral contraceptive, and to discuss the statistical issues involved in the planning and evaluation of the results of such studies.

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