Trials in women

Women of childbearing age have been viewed as a 'vulnerable population' and have been systematically excluded from early clinical trials. A change in attitude and policies occurred in the last decade, with a consequent increa se of women participating in clinical trials. The implications are increasi ng respect for the woman's capacity to make her own risk-benefit choices, e arly evaluation of patients that represent the ultimate user of a drug and equal opportunities for women to benefit from the therapeutic potential of new drugs. Drug trials should be designed to identify sex-related effects a nd to analyse the efficacy and tolerability of antiepileptic drugs (AEDs) b y gender. Further aspects should be considered, including changes in respon se in relation to the menstrual cycle and over the various stages of reprod uctive life; interactions between hormonal therapies and AEDs; the effect o f AEDs on reproductive function and possible consequences of prenatal expos ure to AEDs. These considerations become even more critical when pregnant a nd lactating women are considered, since any risk for the offspring is unac ceptable unless drug administration is likely to have major medical benefit s for the mother. (C) 2001 Elsevier Science B.V. All rights reserved.