If the clinical trial is not of a drug or device subject to FDA regulation, and, thus, not an applicable clinical trial, at the time of the initiation of the trial, then the statement is not required.
Risks of Bioidentical Hormones. The jury's out on whether bio-identical hormones are safer. In 2002, a large federally funded study by the Women's Health Initiative revealed an increased risk of heart disease, breast cancer and stroke in women using synthetic prescription hormone replacement therapy.
1 It is not considered safe to take during pregnancy and may increase the risk of birth defects. 2  Oral progesterone, such as Prometrium, is a natural form of the hormone used to help supplement the luteal phase during fertility treatments such as intrauterine insemination (IUI).