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.
When estrogen and progesterone are used together, the risk of a clot increases. patients with a clotting condition such as Factor V Leiden who were using birth control pills that contained estrogen and progesterone can have up to a 35 fold higher risk of a clot.