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.
Because many birth control pills contain estrogen and progestin, women aged 18-45 are exposed to increased estrogen levels in their blood. Not only does estrogren increase the risk of clotting, but it is also assumed to be the cause of increased risk of blood clots during a pregnancy. While estrogen does increase the chance of blood clots forming, the absolute risk of a clot forming in women who take birth control is still relatively small.