Effect of Obesity on the Effectiveness of Hormonal Contraceptives

In recent years, regulators and clinicians have become increasingly aware of the limitations of clinical trials conducted in highly controlled settings with very selective populations. The US Food and Drug Administration (FDA) and others have urged drug developers and researchers to increase the diversity of study populations in clinical trials by conducting pragmatic, multiregional studies to demonstrate contraceptive effectiveness in “real-world” populations who are likely to be future users of the tested products [ 1 Califf R.M. Sugarman J. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials. 2015; 12: 436-441 Crossref PubMed Scopus (128) Google Scholar , 2 Ford I. Norrie J. Pragmatic trials. N Engl J Med. 2016; 375: 454-463 Crossref PubMed Scopus (713) Google Scholar ].