Randomized controlled trials often exclude women who are pregnant, lactating, or of reproductive potential, raising ethical and health issues regarding autonomy, beneficence, and fairness. This exclusion leads to a delay in obtaining relevant evidence, which is then only collected in clinical practice, often with a delay of several years. The article highlights the need to include these women in clinical trials to improve the scientific quality and safety of treatment for this group. At the same time, the inclusion of pregnant and lactating women brings regulatory challenges that need to be addressed based on health and ethical principles. The authors point out that the exclusion of these women from clinical trials may lead to incomplete or delayed information about the effects of drugs in these groups. Discussion of this issue is important for improving access to treatment and protecting the rights of patients with reproductive potential. The aim is to promote a balance between health protection and respect for women's autonomy in clinical research.