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.
CHICAGO -- The effect of 17-alpha-hydroxyprogesterone caproate on preterm birth varies depending on the presence or absence of cerclage in high-risk women, according to a planned secondary analysis of the Vaginal Ultrasound Cerclage Trial.